Validation Engineer

4 months ago


Cambridge, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Provide validation subject matter expertise / support for equipment and systems in use at Client site which includes Analytical Instruments, Manufacturing Operation Units and CTUs (Controlled Temperature Units).
  • Ensure the validated status of site facilities, utilities, equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
  • Draft, review, approve and execute Assessments, URS, IOQ and PQ protocols and Summary Reports for Equipment and Systems.
  • Maintain Periodic Review and Continuing Qualification program for existing equipment and systems.
  • Provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities.
  • Prepare protocols and reports for validation and revalidation work
  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects.
Requirements:
  • Extensive knowledge of quality systems and performing system impact assessments.
  • Knowledge in 21CFR Part 11 and Data Integrity.
  • Strong understanding of validation principles including but not limited to FEU, cleaning, process and computer systems.
  • Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission/inspection.
  • Experience using Kneat is a plus.
  • ble to work effectively as a part of a cross functional team and maintain good relationships with internal and external stakeholders.
  • Strong interpersonal and communication skills
  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
  • Bachelor's degree in engineering, Science or related technical field.
  • 5-7 years in CQV experience in cGMP manufacturing with experience in Analytical/Lab instruments qualification.

  • Validation Engineer

    2 months ago


    Cambridge, United States Beacon Hill Full time

    Beacon Hill Life Sciences is seeking a qualified Validation Engineer to join our client's team on-site in both Lexington and Cambridge, MA. This is a 6-month contract role with opportunity to extend; without remote capability. Project:Our client is looking a for an Equipment Validation Engineer to support the installation of new Laboratory Equipment. The...

  • Validation Engineer

    2 months ago


    Cambridge, United States Beacon Hill Full time

    Beacon Hill Life Sciences is seeking a qualified Validation Engineer to join our client's team on-site in both Lexington and Cambridge, MA. This is a 6-month contract role with opportunity to extend; without remote capability. Project:Our client is looking a for an Equipment Validation Engineer to support the installation of new Laboratory Equipment. The...

  • Validation Engineer

    5 days ago


    Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job Title: Validation EngineerVericel Corporation is seeking a highly skilled Validation Engineer to join our team in Cambridge, MA. As a key member of our validation team, you will be responsible for performing validation in a GMP biotech manufacturing facility.Key Responsibilities:Develop and execute validation project plans and protocols.Participate in...


  • Cambridge, United States Validation & Engineering Group Full 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...


  • Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing validation professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics....


  • Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing validation professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...


  • Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing validation professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...


  • Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job SummaryThis role will be based in our Cambridge, MA location until our new state-of-the-art facility located in Burlington, MA is ready.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top-performing validation professional looking to contribute to a...


  • Cambridge, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job DescriptionJob DescriptionResponsibilities:· Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and...


  • Cambridge, Massachusetts, United States Beacon Hill Full time

    Company Overview:Beacon Hill Life Sciences is currently seeking a skilled Validation Engineer to contribute to our client's operations. This role is focused on the validation of laboratory equipment and is a contract position.Project Overview:The client requires an Equipment Validation Engineer to assist with the setup and validation of new laboratory...


  • Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job Title: GxP Validation Engineer/AnalystWe are seeking a highly skilled GxP Validation Engineer/Analyst to join our team at White Collar Technologies Inc. This role will be responsible for providing support to the QC Analytical department in maintaining CGMP status of QC Instrumentation hardware and software, as well as performing comparability studies for...


  • Cambridge, Massachusetts, United States Vericel® Corporation Full time

    Job Title: Validation Engineer IIVericel Corporation, a leading innovator in advanced therapies for sports medicine and severe burn care, seeks a skilled Validation Engineer II to join our team. As a key member of our Validation Management group, you will play a critical role in ensuring the quality and integrity of our products.Key Responsibilities:Develop...


  • Cambridge, Massachusetts, United States Vericel® Corporation Full time

    Validation Engineer IIVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a skilled Validation Engineer II to join our team. As a key member of our validation team, you will be responsible for performing validation in a GMP biotech manufacturing facility.Key Responsibilities:Develop and execute...


  • Cambridge, Massachusetts, United States Beacon Hill Full time

    Company Overview:Beacon Hill Life Sciences is actively seeking a skilled Validation Engineer to support critical projects in the biotechnology and pharmaceutical sectors.Role Overview:This position focuses on the validation of new laboratory equipment, ensuring compliance with industry standards and regulations. The successful candidate will possess an...

  • Validation Specialist

    4 months ago


    Cambridge, United States Mentor Technical Group Full time

    Job DescriptionJob DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and...


  • Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job OverviewWe are seeking a GxP Compliance Validation Specialist to provide essential support to our Quality Control Analytical department. This role is pivotal in ensuring the CGMP status of our QC Instrumentation hardware and software while conducting comparability studies for the integration of analytical assays on new instruments.Key...

  • Aerospace Engineer

    5 days ago


    Cambridge, Massachusetts, United States Aurora Flight Sciences Full time

    Job Title: Loads and Dynamics EngineerAurora Flight Sciences, a Boeing Company, is seeking a talented and self-motivated Loads and Dynamics Engineer to join our team.Job Summary:We are looking for a skilled engineer to develop and interpret aeroelastic loads and stability, perform sensitivity studies and trades studies, and develop loads plans and required...


  • Cambridge, Massachusetts, United States Sequoia Biotech Consulting Full time

    Job Title: Principal Automation EngineerSequoia Biotech Consulting is seeking a highly skilled Principal Automation Engineer to join our team. As a key member of our Engineering Group, you will be responsible for providing instrumentation and control engineering capabilities and expertise to support the development and implementation of process, utility, and...


  • Cambridge, Massachusetts, United States Amgen Full time

    Job Title: Principal Engineer Systems EngineeringAmgen is seeking a highly skilled Principal Engineer Systems Engineering to join our team. As a key member of our engineering organization, you will be responsible for ensuring the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility...


  • Cambridge, United States Intellectt Inc Full time

    Job Title: Medical Device Senior Manufacturing EngineerLocation: Cambridge, MA.Duration: 12+ MonthsJob Description : Job Overview:The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new products. The Sr. Manufacturing Engineer will also...