Job DescriptionJob Description

DeVine is a leading provider of Technical and Scientific solutions for Federal, State and commercial clients.  

Our company is looking for a Python Programmer, with Secret Clearance, to join our team at Stennis Space Center in Mississippi.  This onsite position will be supporting a government customer, hence only US Citizens may be considered.

The Python Programmer will join DeVine and will work with our customer supporting projects in applied Meteorology, Oceanography (METOC), etc.  If you enjoy working hard, having fun, and seeing your effort make an impact in our Nation, and the World at large, then please apply!

Required Experience with:

1+ years' programming experience with PythonBachelor's Degree in Computer Science or related fieldCoordinating support for projects that involve multiple stakeholders, participating in related meetings, writing reports and tracking progress Current Secret Clearance

Preferred Experience:

Experience with Anaconda, automation and dockerizationJava experience a plus4D modelling, METOC, NetCDFMachine Learning (ML)Dockerized interface development for UUV sensors a plusWriting custom scriptsSetting up scripts for testing custom processing pipelinesSecurity Technical Implementation Guides (STIGs), especially in regards to Navy systems

About the position: 

Position Type: Full-time
Location: Stennis Space Center, MS
Benefits: Medical, Dental, Vision, 401k, Life Insurance, Paid Holidays, Paid Sick Leave and Paid Vacation
Compensation: $70K-76K per year DOE and skills

Equal Opportunity Employer 

We are committed to a policy of assuring that all applicants for employment are recruited, hired and assigned on the basis of qualifications and merit without discrimination based on any protected classification, including, but not limited to, race, color, religion, sex, sexual orientation, national origin, veteran status, age, disability, handicap, marital status, or any other characteristic protected by applicable laws.  

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Job DescriptionJob Description

Instrument Test Technician I
Location: Sparks Glencoe, MD
Schedule: Monday–Friday | Day Shift
Pay Rate: $25.00/hour

Job Overview

The Instrument Test Technician I performs production assembly operations along with complete system analysis, testing, and performance optimization of moderately complex instruments. This role involves basic electrical, mechanical, and software troubleshooting to diagnose issues in non-functioning test equipment and implement solutions based on defined pass/fail criteria. The technician identifies and escalates testing issues and serves as a subject matter expert in instrument functional performance.

Key Responsibilities

Build, integrate, and understand the full assembly process and requirements for instruments in the production areaExecute and interpret test instructions for at least one moderately complex instrument, including functional and release testingAnalyze test results and data to determine pass/fail outcomes and recommend corrective actionsOptimize system performance, including precision of movement and/or light systems, using test dataIdentify defects and recommend design or process improvementsRead and interpret drawings, work instructions, and workmanship standardsTrain and support associates in mechanical assembly and testing activitiesComplete production activities in compliance with regulatory requirements and BD safety and quality standardsProcess and disposition Quality Notifications (QNs)Interface with Manufacturing Engineering, Quality, Planning, and Purchasing teams as neededPerform material handling for raw materials and sub-assembliesMaintain a safe, clean, and organized work environment in accordance with housekeeping standardsFollow Good Manufacturing Practices (GMP), safety policies, and company proceduresWork overtime as required to meet business needsPerform other duties as assigned

Qualifications

Education & Experience

High School Diploma or GED with 6 years of manufacturing experience, orAssociate (AA) technical degree with 2 years of manufacturing experienceExperience working in a regulated manufacturing environment is required

Required Skills & Competencies

Ability to support testing of moderately complex instrumentsProven leadership skills with the ability to mentor and coach other associatesStrong accountability for results and continuous process improvementDemonstrated commitment to Continuous Improvement and Lean Manufacturing principlesExperience with mechanical tools (e.g., torque drivers, gauges, bits)Proficiency in reading drawings and measuring/interpreting dimensions and requirementsEffective time management across multiple production ordersStrong teamwork and collaboration skillsAbility to work within established quality systems and proceduresFlexibility to manage frequent changes in assignments

Technical & Professional Skills

Proficient in English (reading, writing, and basic documentation)Ability to analyze charts, follow diagrams, and perform basic arithmeticBasic computer skills, including use of Windows-based systemsStrong math and analytical capabilitiesAbility to use independent judgment to plan work, troubleshoot, and problem-solveStrong communication and leadership skills

If you are interested, please send an up-to-date resume to jschafer@alinestaffing.com Read Less

Job DescriptionJob DescriptionSalary: $110,000 $150,000

Intreped Partners, LLC (including its subsidiary Global Systems Engineering, LLC) is seeking a Senior Energy Management Control Systems (EMCS) Service Administrator / Site Lead to support operations at Joint Base Andrews, Maryland. This role serves as the primary technical and operational lead, responsible for overall EMCS performance, coordination with Government stakeholders, and supervision of on-site activities.

The position supports a Siemens Desigo/Apogee-based EMCS environment and requires deep experience in building automation systems within large-scale or federal facilities.

Key Responsibilities

Serve as the primary interface to the Contracting Officers Representative (COR) and Base Energy ManagerOversee daily EMCS operations, including monitoring, troubleshooting, and system optimizationLead preventive maintenance planning and executionManage monthly energy reporting, daily alarm reporting, and system documentationSupport and oversee HVAC system modifications and control sequence updatesDevelop and maintain system graphics and integrationsPerform and oversee system backups, diagnostics, and inspectionsCoordinate routine service activities and emergency response supportEnsure compliance with UFC 4-010-06 (ICS cybersecurity) and RMF/ATO requirementsSupport demand response and power shedding eventsProvide technical oversight of system upgrades, enhancements, and expansions

Required Qualifications

Minimum of 5 years of experience in Building Automation Systems (BAS) or EMCSHands-on experience with installation, maintenance, and troubleshooting of BAS/EMCS systemsDemonstrated experience with Siemens Desigo, Apogee, or Insight systems (strongly preferred)Experience supporting federal, Department of Defense (DoD), or large campus environments (preferred)Strong understanding of HVAC systems, control sequences, and system optimizationKnowledge of BAS networks, controllers, and field devicesProven ability to lead operations and effectively interface with Government stakeholders

Security & Access Requirements

Ability to obtain and maintain a DoD-issued security clearance (U.S. citizenship is required to obtain a clearance)Ability to pass a background investigation and obtain base accessAbility to work within a secure, air-gapped ICS environment

Work Requirements

100% on-site at Joint Base Andrews, MDParticipation in after-hours and emergency response coordination as needed

What We Offer

Intreped Partners provides a comprehensive total rewards package designed to support our employees well-being, growth, and success, including competitive compensation, robust health benefits, retirement savings with company match, generous paid leave, and opportunities for professional development and advancement.

Equal Employment Opportunity Statement

Global Systems Engineering, LLC (GSE), a subsidiary of Intreped Partners, LLC, is an Equal Opportunity Employer committed to fostering an inclusive and diverse workplace. Intreped Partners, LLC provides equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, physical or mental disability, genetic information, marital status, citizenship status, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Intreped Partners, LLC takes affirmative action to ensure equal opportunity in all aspects of employment, including recruitment, hiring, promotion, compensation, benefits, training, and termination.

Intreped Partners, LLC will not discriminate or retaliate against applicants or employees who inquire about, discuss, or disclose their compensation or that of others.

Intreped Partners, LLC considers qualified applicants with criminal histories in a manner consistent with applicable laws.

Intreped Partners, LLC participates in the E-Verify program where required by law.

Intreped Partners, LLC is committed to providing reasonable accommodations to applicants with disabilities and for sincerely held religious beliefs.

Intreped Partners, LLC maintains a drug-free workplace.

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Job DescriptionJob Description

Resumen:

El/la Asistente Administrativo será responsable de brindar apoyo directo al personal de supervisión del proyecto, manejando procesos administrativos clave como nómina, hojas de asistencia, documentación de empleados, coordinación con suplidores y seguimiento de materiales. La posición incluye el manejo de documentación requerida para el acceso de empleados a la base, incluyendo la Forma 369 y evidencias de adiestramientos (AT Level 1 y OPSEC), así como la preparación de informes, documentación de accidentes y apoyo operacional diario. Su función es asegurar el orden, cumplimiento y flujo eficiente de información dentro del proyecto.

Descripción del Puesto:

Preparar y dar apoyo en los procesos de nómina del personal del proyecto.Revisar, archivar y entregar documentación de AHA’s conforme a los requisitos establecidos.Preparar y mantener actualizadas las hojas de asistencia tanto de oficina como de campo.Procesar check requests según los procedimientos internos.Coordinar y documentar suplidores relacionados a compras deI. DieselII. AgregadosIII. HormigónManejar la documentación requerida para el acceso de empleados a la base, incluyendo:I. Forma 369II. Evidencia de adiestramientos AT Level 1· III. OPSEC

Administrar la documentación de empleados relacionada a:

· I.Vacaciones

II.Enfermedad

Dar seguimiento continuo al estatus de materiales.Coordinar la entrega de cheques a suplidores.Mantener organizada la documentación, materiales y misceláneos de oficina.Coordinar y dar seguimiento al runner del proyecto.Realizar impresión de planos según solicitado.Redactar informes solicitados por el Departamento de Recursos Humanos.Documentar accidentes de empleados conforme a los protocolos establecidos.Llevar y coordinar el registro de la labor diaria de empleados.Completar formularios y reportes de pruebas de campo.Mantener la organización y limpieza del área administrativa.Otras tareas a ser asignadas.

Division 16 LLC está comprometida con la creación de un ambiente de trabajo inclusivo donde se valoren la diversidad y la igualdad. No se discrimina a ninguna persona por razones de raza, color, credo, religión, género, edad, orientación sexual, origen nacional, discapacidad, condición de veterano u otra característica protegida por leyes federales, estatales y locales. La empresa garantiza que todos los candidatos sean considerados y que todos los empleados sean tratados con justicia y dignidad. Division 16 LLC no tolera ningún tipo de discriminación o acoso en el lugar de trabajo.

Division 16 LLC es un empleador que ofrece igualdad de oportunidades en el empleo.

Patrono con Política de Empresa Libre de Drogas

Residentes Sección 3

Nuestro Compromiso con la Diversidad e Inclusión:

En Division 16, LLC, creemos que la diversidad enriquece nuestra organización. Estamos comprometidos a construir un equipo inclusivo donde todos los empleados se sientan valorados y respetados, sin importar su origen, género, identidad de género, orientación sexual, edad, discapacidad o cualquier otra característica que nos haga únicos. Fomentamos un ambiente de trabajo donde se celebre la diversidad y se promueva la igualdad de oportunidades para todos.

Únete a nuestro equipo y sé parte de una compañía que valora y fomenta la diversidad e inclusión!

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Job DescriptionJob Description

Descripción

El/la gerente debe asegurar el cumplimiento de los procesos necesarios para el funcionamiento de la compañía. Será responsable de mantener orden en su localidad, supervisión de empleados y realizar recomendaciones para la mejorar el servicio al cliente.

Funciones y responsabilidades

Cumplir cabalmente con todo el proceso de preparación para abrir y cerrar tienda.Supervisar la labor de los empleados asignados durante su turno para asegurar el cumplimiento de los objetivos en ventas, costos, retención de empleados, servicio y satisfacción de los clientes.Ordenar y recibir mercancía diaria y/o semanalmente. Cuadres de cajas registradoras.Dar apoyo en todas las áreas de la tienda.Análisis para la toma de decisiones, establecer y ejecutar planes de trabajos diarios y semanalmente.Someter informes periódicos según sean requeridos.Hacer recomendaciones sobre mejoras en la tienda, entre otras responsabilidades según la necesidad operacional.

Requisitos

Mínimo un grado Asociado en Gerencia & Administración y/o Mercadeo completado.Dos años mínimos de experiencia en puesto gerencial y supervisión de empleados en ventas al detalDisponible para trabajar horarios flexibles, sábado, domingo, días feriados, diurnos, nocturnos y rotativos.Conocimiento básico del idioma inglés y avanzado en español (hablado, escrito y leído)Experiencia en Servicio al Cliente

Habilidades

Habilidad para resolver problemas, trabajar bajo presión y seguir instrucciones.Buen manejo del tiempo.Habilidad para manejar múltiples tareas. Organizado/a.Habilidad para trabajar bajo poca supervisión.Atención al detalle.Conocimiento tecnológico. Manejo de recibo, inventario y compra.

Patrono con igualdad de oportunidad en el empleo.

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Job DescriptionJob Description

Descripción

El/la gerente debe asegurar el cumplimiento de los procesos necesarios para el funcionamiento de la compañía. Será responsable de mantener orden en su localidad, supervisión de empleados y realizar recomendaciones para la mejorar el servicio al cliente.

Funciones y responsabilidades

Cumplir cabalmente con todo el proceso de preparación para abrir y cerrar tienda.Supervisar la labor de los empleados asignados durante su turno para asegurar el cumplimiento de los objetivos en ventas, costos, retención de empleados, servicio y satisfacción de los clientes.Ordenar y recibir mercancía diaria y/o semanalmente. Cuadres de cajas registradoras.Dar apoyo en todas las áreas de la tienda.Análisis para la toma de decisiones, establecer y ejecutar planes de trabajos diarios y semanalmente.Someter informes periódicos según sean requeridos.Hacer recomendaciones sobre mejoras en la tienda, entre otras responsabilidades según la necesidad operacional.

Requisitos

Mínimo un grado Asociado en Gerencia & Administración y/o Mercadeo completado.Dos años mínimos de experiencia en puesto gerencial y supervisión de empleados en ventas al detalDisponible para trabajar horarios flexibles, sábado, domingo, días feriados, diurnos, nocturnos y rotativos.Conocimiento básico del idioma inglés y avanzado en español (hablado, escrito y leído)Experiencia en Servicio al Cliente

Habilidades

Habilidad para resolver problemas, trabajar bajo presión y seguir instrucciones.Buen manejo del tiempo.Habilidad para manejar múltiples tareas. Organizado/a.Habilidad para trabajar bajo poca supervisión.Atención al detalle.Conocimiento tecnológico. Manejo de recibo, inventario y compra.

Patrono con igualdad de oportunidad en el empleo.

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Job DescriptionJob DescriptionThe Financial Systems Analyst provides technical and analytical support in the preparation, evaluation, and management of organizational budgets. This role ensures that budget estimates are accurate, complete, and aligned with established regulations and objectives. Responsibilities include reviewing financial requests, performing cost-benefit analyses, evaluating program performance, and researching financial and economic trends that impact spending. The analyst also assists in developing budget policies and may conduct training on financial procedures.

General Duties:
• Provide advice and technical support for annual budget preparation.
• Measure organizational performance and assess program or policy impacts on the budget.
• Review budget estimates and proposals for completeness, accuracy, and compliance.
• Conduct cost-benefit analyses to evaluate funding requests and tradeoffs.
• Examine historical and current financial data to support forecasting.
• Research financial and economic developments affecting organizational spending.
• Develop policies and guidelines for budget formulation and maintenance.
• Conduct training sessions on new or updated budget procedures.
• Prepare written and oral reports presenting findings and recommendations.

Salary: $85k year

Required Education:
• Bachelor's degree in business, finance, accounting, or a related field.

Required Experience:
• 3 years of experience in a related financial, accounting, or analytical field.

Skills & Competencies:
• Strong analytical and financial evaluation skills.
• Proficiency with financial systems, spreadsheets, and related tools.
• Ability to analyze complex financial data and prepare forecasts.
• Strong written and verbal communication skills.
• Ability to interpret and apply financial regulations and budget procedures.
• Excellent attention to detail and organizational abilities.

What Your Experience Working for Us Will Be Like
Ask any of our employees and they will tell you SSI is a great place to work with an upbeat and positive culture. We take pride in our work to continuously improve on our performance in a manner that enhances the mission of the agencies we serve while expanding opportunities for our employees and our company.

About Synectic Solutions, Inc. (SSI)
Synectic Solutions, Inc. (SSI), is an award-winning, 20-year government contracting agency focused on the areas of logistics, engineering, management, and information technology. SSI is a growing organization committed to exceeding customer expectations, to continually improving all products, services, and processes, and to perform all work with the commitment to upholding the highest standards and ethics.

Ready to apply?
If this job sounds like a fit for you, then click on the ‘apply’ button below. Good luck!

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Job DescriptionJob DescriptionThe Computer Programmer IV recommends the redesign of programs, investigates and analyzes feasibility and program requirements, and develops programming specifications. Assigned programs typically affect a broad multi-user computer system which meets the data processing needs of a broad area (e.g., manufacturing, logistics planning, finance management, human resources, or material management) or a computer system for a project in engineering, research, accounting, statistics, etc. This Programmer plans the full range of programming actions to produce several interrelated but different products from numerous and diverse data elements, which are usually from different sources.

General Duties:Develop. modify, and maintain complex programs; designs and implements the interrelations of files and records within programs which will effectively fit into the overall design of the project.Works with problems or concepts and develops programs for the solution to major scientific computational problems requiring the analysis and development of logical or mathematical descriptions of functions to be programmed.Develops occasional special programs, e.g. a critical path analysis program to assist in managing a special project. Test, document, and write operating instructions for 54 all work, confers with other EDP personnel to secure information, investigate and resolve problems, and coordinates work efforts. Preform programming analyses as: investigating the feasibility of alternate program design approaches to determine the best-balanced solution.Facilitate subsequent modification and conserve resources.Asist user personnel in defining problems or needs, determining work organization on typical maintenance projects and smaller scale, working on limited new projects
Requirements:High School Diploma and US CitizenMust have and Active DoD Clearance Minimum of 3+ years of professional experience as a Computer Programmer within a DoD environment. Salary: $27.63 per hour

Skills & Competencies:Strong administrative and organizational management skills.Proficient with Microsoft Office applications.Excellent written and verbal communication skills.Work independently under overall objectives and direction, apprising the supervisor about progress and unusual complications and modifying and adapting precedent solutions and proven approaches.Ability to complete work is reviewed for timeliness, compatibility with other work, and effectiveness in meeting requirements. 
What Your Experience Working for Us Will Be Like
Ask any of our employees and they will tell you SSI is a great place to work with an upbeat and positive culture. We take pride in our work to continuously improve on our performance in a manner that enhances the mission of the agencies we serve while expanding opportunities for our employees and our company.

About Synectic Solutions, Inc. (SSI)
Synectic Solutions, Inc. (SSI), is an award-winning, 20-year government contracting agency focused on the areas of logistics, engineering, management, and information technology. SSI is a growing organization committed to exceeding customer expectations, to continually improving all products, services, and processes, and to perform all work with the commitment to upholding the highest standards and ethics.

Ready to apply?
If this job sounds like a fit for you, then click on the ‘apply’ button below. Good luck!

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Job DescriptionJob DescriptionThe Configuration Management (CM) Specialist I supports the management, control, and tracking of hardware, software, documentation, and product configuration data throughout system life cycles. The role assists in maintaining configuration baselines, documenting changes, coordinating with engineering teams, and supporting Configuration Control Board (CCB) activities. 

General Duties:
• Maintain and update configuration item (CI) lists, baselines, and CM records.
• Support configuration identification, control, status accounting, and audits.
• Process and track change requests, engineering change proposals, and updates.
• Assist in preparing CCB documentation, agendas, logs, and decision records.
• Maintain documentation repositories and version-control structures.
• Support release management activities for hardware, software, and documentation.
• Ensure CM processes align with organizational standards and life cycle management requirements.
• Collaborate with engineering, IT, logistics, and program teams to support CM activities.
• Identify configuration discrepancies and assist in resolving CM issues.

Salary: $75k year

Required Education:
• Bachelor's degree in any field.

Required Experience:
• 3 years of professional experience in configuration management or a related technical discipline.

Skills & Competencies:
• Knowledge of CM principles, standards, and best practices.
• Experience with configuration tracking tools and version-control systems.
• Strong organizational, documentation, and communication skills.
• Ability to manage multiple tasks and maintain accuracy.
• Familiarity with engineering documentation and product release processes.

Work Environment:
• Works collaboratively with technical and program teams.
• Requires strong attention to detail and commitment to CM discipline.

What Your Experience Working for Us Will Be Like
Ask any of our employees and they will tell you SSI is a great place to work with an upbeat and positive culture. We take pride in our work to continuously improve on our performance in a manner that enhances the mission of the agencies we serve while expanding opportunities for our employees and our company.

About Synectic Solutions, Inc. (SSI)
Synectic Solutions, Inc. (SSI), is an award-winning, 20-year government contracting agency focused on the areas of logistics, engineering, management, and information technology. SSI is a growing organization committed to exceeding customer expectations, to continually improving all products, services, and processes, and to perform all work with the commitment to upholding the highest standards and ethics.

Ready to apply?
If this job sounds like a fit for you, then click on the ‘apply’ button below. Good luck!

 

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Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist - CIP

Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.

Key Responsibilities:

Commissioning & Qualification Execution:

Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance:

Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.Ensure traceability from design specifications through executed testing.Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.Prepare summary reports for Quality Assurance approval.

Cross-functional Collaboration:

Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.Support operations during process validation batches and cleaning validation campaigns.Provide training and technical guidance to CQV engineers and contractors executing test protocols.

Qualifications:

Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.Experience in generating and executing documentation for CQV activities.Strong knowledge of cleaning validation, sterilization principles, and automation integration.Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines.Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications.Experience executing or overseeing FAT/SAT, IOQ, PQ activities.Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).Must be fully bilingual (English / Spanish) with excellent oral skills.Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Read Less