Validation & 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 / SchedulerQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 5 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.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.Strong knowledge (according to related area). Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.Responsibilities:
Gather and maintain project time frame and budget for CRI TCCC multiple projects schedule.Maintains schedules, milestones by means of a detailed Gantt Chart.Verify that tasks related to the project’s progress stay on scope.Maintains project owners informed and documented of each project performance.Reviews projects status with each project manager and modifies schedules as needed.Prepares reports and keeps management informed of project status and related issues.Maintains communication with stakeholders, providers, and contractors, as related to project activities and schedules updates.Maintain projects performance metrics: • Project Time schedule • Comparisons with project baseline • Adherence to project critical pathCoordinates project tasks with other units to ensure goals and requirements are met.Adhere to environmental and EH&S policies and procedures.Support for financial reports at the end of each month, quarter, and year. Read LessValidation & 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:
Senior EngineerEducation:
Doctorate ORMasters + 2 years of Engineering experience ORBachelors in Engineering + 4 years of Engineering experience.Attributes:
• Experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls. Initiate, revise, and approve manufacturing-controlled documents in the document management system. Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
• Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals. Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development. Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
• Assist in the development and execution of process validation protocols and reports. Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire). Ensure configurations align with process design, GMP requirements, and Amgen guidelines. Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
• Use Application Life Cycle Management (ALM) system during validations and navigate SAP for master data, process orders, production versions, inventory, and bill of materials (BOMs). Ensure SAP-MES PAS/X connectivity, troubleshoot IDoc communication issues, and maintain alignment between SAP and MES configurations, particularly for BOM accuracy and process integration.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support. Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.
Validation & 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:
Specialist QA2100 to 0530 AST (M – F)SUMMARY
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
EDUCATION
-Bachelors + 4 years of directly related experience OR
COMPETENCIES/SKILLS
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
PREFERRED:
Supply ChainIncoming sampling and inspectionQuality audit of warehouse floor operationsProficient in Smartsheet, Generative AI, Power BI, SAPInitiating and approving Quality deviations (nonconformances) Read LessValidation & 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 Engineer / Validation SpecialistJob Summary:
We are seeking a detail-oriented Manufacturing Engineer / Validation Specialist to join our team. The ideal candidate will be responsible for designing, implementing, and maintaining manufacturing processes in compliance with regulatory standards. Additionally, this role will involve validating equipment and processes to ensure efficiency and quality in our manufacturing operations.
Qualifications:
- Bachelor's degree in Engineering.
- 2-5 years Equipment and Process Validation experience.
- Proven experience in manufacturing engineering and validation processes.
- Familiarity with regulatory requirements in the manufacturing industry.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
Responsibilities:
- Develop and maintain manufacturing processes, procedures, and documentation.
- Coordinate and execute validation activities for manufacturing equipment and processes.
- Ensure compliance with regulatory standards and best practices.
- Identify areas for process improvement and implement solutions.
- Collaborate with cross-functional teams to drive efficiency and quality in manufacturing operations.
Preferred Qualifications:
- Certification in Lean Six Sigma or other process improvement methodologies.
- Experience working with Molding and Laser equipment.
- Knowledge of risk management principles in manufacturing.
Validation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & 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:
Document Management Lead / Document ControllerOversee the lifecycle of documents for Key Projects ensuring alignment with timelines. Collaborates with cross-functional teams to assess documentation requirements.Oversee the creation, review and approval cycle of documents including SOPs, validation protocol, drawings and project plans.Identify documents impacted by several projects and align, negotiate and control review/approval process. Develop and maintain manual and/or digital tracking systems for document status. Prepare reports to identify documents due for review / approval.Qualifications:
Bachelor's Degree in Science or Business.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read Less