Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Talent Acquisition Specialist IDescription:Handle hiring requests including:Collecting the hiring demands: Working alongside the Sales Department to finalize the hiring demands & JDs as well as fulfillment timeline.Sourcing: search passive and active candidates and approach for the right opening jobs.Selection: phone interview, schedule interview, assign technical test, joining interview, prepare candidate assessment form, etc.Oversighting the hiring process & progress;Offering: prepare the offer, call the candidate to discuss the offer and relevant information, be prepared to negotiate during the process if necessary, follow up with the candidate until the final decision is made, and update newcomer information on the portal.Maintain consistent communication with candidates throughout their candidacy process. Deliver updates including but not limited to rejection notification.Advertising jobs openings to attract candidates.Participate in job fairs to maintain a robust pool of candidates.Making relevant reports: weekly, monthly, and quarterly.Proactively build passive candidate pipeline to enlarge the Talent Pool.Qualifications:Bachelor's Degree in Human Resources or related.At least 1 year of experience managing all phases of the recruitment and hiring process.At least 1 year of experience recruiting for the manufacturing industry (Pharma, Medical Devices or Biotechnology).At least 2 year of experience recruiting for hourly positions.At least 3 years of experience working with Excel, Word, Power Point, MS Outlook and Share Point.Experience working with Applicant Tracking Systems.A high level of professionalism and discretion, this role will be across confidential employee data.A genuinely pro-active and helpful attitude, with a strong work ethic and excellent attention to details.Initiative and confidence to work autonomously when required.Ability to handle and effectively prioritize a diverse and changing workload.Strong communication skills with ability to speak to a wide range of people at all levels.Ability to work under pressure and in a fast pace environment.Ability to quickly adapt to changes.Organization skills.Excellent verbal and written communication skills in both English and Spanish.This is an on-site position at Guaynabo, PR.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Manufacturing Technician - ParenteralGENERAL INFORMATION:1. Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.
• Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
• Cleans, sanitize, and sterilize manufacturing area rooms and equipment.
• Runs autoclaves to sterilize equipment to be used in the manufacturing process.
• Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
• Performs integrity test of all filters used in the process before and after each use.
• Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
• Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
• Performs sampling of bulk solutions as per batch record requirements.
• Interacts with computer controlled equipment and processes.
• Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
• Verifies calibration status of critical instruments before process operation.
• Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves as required. Complete production documentation legible, error free and on time following good documentation practices.
2. Ensures the completeness and compliance of all required documentation during the manufacturing process.
• Maintains inventory and request all necessary components and operating materials.
• Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
• Completes production documentation legible, error free and on time following good documentation practices.
• Audits batch records and documentation, as required.
• Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOP’s before performing the formulation process.
Revises and improves procedures and develops new SOPs based on observations and experiences.
3. Provides assistance and supports to manufacturing related activities
• Initiates, participates, and assists in resolution of quality investigations.
• Assists in “on the job training” for new employees.
• Participates in special projects and during audits and regulatory inspections as required.
• Participates and assists in area validation and qualification activities.
• Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
• Supports Annual Requalification Program by assuring plan execution on established timeframe.
• Assists manufacturing activities in other areas within operations as required.
• Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision, as requested by supervisor.
4. Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.
• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Handles Hazardous and Non hazardous waste according to EHS procedures.
• Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
KNOWLEDGE/ EDUCATION/ EXPERIENCE:
• High school diploma with, two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process.
• Knowledge of preparation, formulation and filling processes.
• Basic writing skills when completing area documentation.
• Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
• Ability to work with minimum supervision.
• Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
• Knowledge of all critical process parameters and their impact in product quality.
• Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology. .
• Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
• Ability to apply critical thinking to resolve complex issues.
• Excellent leadership characteristics, accountability and commitment.
• Team player and collaborating skills.
• Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
• Skill in performing detailed tasks and documenting information.
• Ability to enter data into a computer and perform complex process transactions.
• Skill in accurate visual inspection (e.g. product and components defects)
• Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
• Skill in basic mathematical applications.
• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
• Strong organizational skills
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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 for Drug Substance EquipmentQualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in drug substance process / manufacturing areas.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).Strong knowledge in drug substance equipment C&Q (Bioreactors, Mixing, Filtration, Centrifuges, Incubators, Chromatography Systems, Lyophilizers)Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Biologics Support Operator IPurpose:
Perform cleaning, sterilization, weighing and dispensing of materials. Monitor alarm systems. Assemble and
inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic or
non-aseptic environments. Perform process tests and participate in qualification and validation activities as
required.Responsibilities:Inspect manufacturing equipment to monitor that performance is within parameters.Clean and sterilize equipment for manufacturing use.Monitor manufacturing processes using electronic or manual systems and elevate any deviation that could impact the operations to address accordingly.Sample collection and processing as required by the process.Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions.Receive, inspect and verify materials availability to be used for production.Document, audit and timely correct manufacturing electronic or paper batch record discrepancies.Document process and equipment status in the area electronic or manual records.Audit documentation of operational activities and document discrepancies using computerized or manual systems.Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.Qualifications:Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field.No previous experience required.Basic knowledge of laboratory techniques.Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.Basic mechanical and mathematical skills.Basic verbal and written communication skills in English and Spanish.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Inspection & Packaging Operator IMAJOR DUTIES AND RESPONSIBILITIES:Operates automatic and/or semi-automatic inspection equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated inspection for liquid and lyophilized products, including syringes.Operates automatic and semi-automatic packaging equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated packaging and syringes combination products assembly process, when necessary.Cleans all packaging/assembly/inspection lines according to procedures, as needed.Verifies components against the packaging process order.Completes area accurate (error free) documentation required before line star up and during the packaging process, following good documentation practices and delivers it on time.Performs housekeeping and handling of waste according to procedure.Inspects the quality and accuracy of all data printed during the inspection/assembly/packaging processes.Detects discrepancies during the packaging process, performs reworks/re-inspection as required by procedures.Attends to all mandatory training meetings for cGMPs, EHS and company policies.Participates in special projects and during audits and regulatory inspection and assists manufacturing activities in other areas within operations, as required.
KNOWLEDGE:High School DiplomaAt least One (1) year of experience within pharmaceutical industryKnowledge in operating the following inspection/assembling/packaging equipments:Manual inspection booths, Semi-automated inspection equipment (e.g. V-90 Seidenader)Labeler machines for Parenteral productsCartoner machinesCheck weigher and/or scalesElectronic equipmentVision systemsManual assembly/packaging linesSecondary packaging semi-automated equipmentCombination product assembly equipments.Accurate visual inspection (e.g. products and components defects)Knowledgeable in CGMP practices, process area, documentation, safety, EHS and hygiene practices.Good communication and Interpersonal skillsBasic knowledge on computerized system.Good leadership and commitmentAbility to enter data into a computer and perform process transactions.Ability to operate pallet jacks.Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.*The candidate must approve the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Trackwise 8 Quality Management System (QMS) Validation ScientistQualifications:Bachelor's Degree in Science or Engineering.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience validating Trackwise SystemMust be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Strong knowledge in cGxP and regulatory guidance.including GAMP 5Experience with the Computer System Development Lifecycle.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Project Manager for Capital ProjectsQualifications:Bachelor's Degree in Science or Engineering.Minimum of 10 years of experience in project management, with a focus on capital projects.Project are Engineering related such as Installation of AHUs to Manufacturing related projects such as new Ovens or Equipment for Packinging LinesProven track record of successfully managing large-scale, complex projects from initiation to closure.Knowledge of CSV and the Computer System Development Life Cycle (SDLC)Strong leadership and team management skills, with the ability to motivate and inspire cross-functional teams.Excellent communication, negotiation, and conflict resolution skills.Proficiency in project management tools and software.Knowledge of relevant industry regulations, standards, and best practices.Available to work extended hours, possibility of weekends and holidays.Responsibilities:Creating long and short-term plans, including setting targets for milestones, adhering to deadlines and allocating resources.Provide strategic direction and leadership to the capital projects team, ensuring alignment with organizational goals and objectives.Identify potential risks and develop mitigation strategies to minimize project disruptions and ensure successful project delivery.Build and maintain strong relationships with internal and external stakeholders.Coach project engineers within the engineering department.Monitor project budgets and expenditures, identifying variances and implementing corrective actions as necessary to ensure projects remain within budgetary constraints.Track project progress against established timelines, identifying potential delays and implementing strategies to keep projects on schedule.Prepare regular progress reports and updates for senior management.Identify opportunities for process improvement and optimization.Adjusting schedules and targets on the project as needed.Motivating people involved in the project to complete tasks on time.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Pharmaceutical Operator IResponsabilidades Especiales:Responsable de la limpieza, ajuste (S/U) y operación de todo equipo relacionado al proceso de granulación y revestimiento.Responsable del recibo, verificación y uso de la materia prima a utilizarse.Responsable de seguir las instrucciones de la orden de manufactura y procedimientos relacionados; incluyendo seguridad, manejo adecuado, identificación y proceso en toda el área de granulación.Responsable por la calidad, productividad y eficiencia de los procesos bajo su cargo.Responsable del muestreo requerido en las áreas bajo su responsabilidad.Responsable de conocer y operar los siguientes equipos: balanzas, mezcladoras, granulador, molinos, hornos, cernidor, “V-blenders” y preparar soluciones relacionadas al proceso.Requisitos Educativos:Diploma de Escuela Superior y dos (2) años de experiencia en la industria farmacéutica o Grado Técnico de Ingeniería Química completado, de cero (0) a seis (6) meses de experiencia.Conocimientos básicos en calculaciones matemáticas.Conocimientos básicos en el área farmacéutica o industria relacionada.Conocimientos básicos de GMP y Seguridad en el manejo de materiales.Habilidades mecánicas.Destrezas de comunicación básica, verbal y escrita tanto en inglés como español.Ejercer su función dentro de los requerimientos del superior o designado.
Daily Work Schedule Expectations 3rd shift work / Training on 1st shift -must be available to work any shift
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Cleaning Validation - Quality Risk Management - Contamination Control StrategyAttend Cleaning Validation team meetings.Participate in Contamination Control Strategy team discussions.Act as a Subject Matter Expert (SME) to lead Quality Risk Management exercises and draft risk assessment reports.Serve as SME for developing cleaning validation protocols, reports, and executable instructions.Contribute to the review and update of cleaning and contamination control strategy documentation.Demonstrate knowledge of the Change Control Process.Review and update Standard Operating Procedures (SOPs) related to the cleaning program and contamination control strategy.Lead training sessions for manufacturing operators.Preferably familiar with TrackWise and VEEVA systems.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in direct process / manufacturing areas.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) 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:Cleaning Validation - Quality Risk Management - Contamination Control StrategyAttend Cleaning Validation team meetings.Participate in Contamination Control Strategy team discussions.Act as a Subject Matter Expert (SME) to lead Quality Risk Management exercises and draft risk assessment reports.Serve as SME for developing cleaning validation protocols, reports, and executable instructions.Contribute to the review and update of cleaning and contamination control strategy documentation.Demonstrate knowledge of the Change Control Process.Review and update Standard Operating Procedures (SOPs) related to the cleaning program and contamination control strategy.Lead training sessions for manufacturing operators.Preferably familiar with TrackWise and VEEVA systems.Qualifications:Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in direct process / manufacturing areas.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.
