Validation Manager

5 days ago


Durham, North Carolina, United States Beam Therapeutics Inc. Full time
Job Title: Validation Manager

Beam Therapeutics Inc. is seeking a highly skilled Validation Manager to join our team. As a key member of our Global Quality Assurance team, you will be responsible for leading the Commissioning, Qualification, and Validation (CQV) program, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:
  • Develop and implement CQV strategies to support Beam's global operations
  • Lead CQV/CSV projects, including creation, execution, and close-out of technical/validation activities and deliverables
  • Maintain the validation program, including policies, SOPs, plans, and other required documents
  • Collaborate with GMP functions onsite and globally to provide continuous improvement of the validation program
  • Ensure cGMP principles are implemented and adhered to during execution of validation-related activities
Requirements:
  • Bachelor's or Advanced degree in a scientific discipline
  • 5-8 years of experience in the pharmaceutical/biotech industry, with a focus on drug substance/drug product manufacture, development, and/or quality
  • 3-5 years of project management experience, including support of large capital projects
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions
  • Solid knowledge of global regulations and standards, with experience interacting with regulatory health authorities at pre- and post-approval inspections
What We Offer:
  • A dynamic and values-driven organization committed to its people and cutting-edge science
  • A collaborative and innovative work environment
  • Opportunities for professional growth and development


  • Durham, North Carolina, United States PSC Biotech Full time

    Job Title: Validation Project ManagerPSC Biotech is seeking an experienced Validation Project Manager to join our team. As a key member of our validation team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key Responsibilities:Develop and implement validation plans,...


  • Durham, North Carolina, United States PSC Biotech Corporation Full time

    About the RolePSC Biotech Corporation is seeking an experienced Validation Project Manager to join our team. As a key member of our global team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key ResponsibilitiesDevelop and implement validation plans, protocols, and...


  • Durham, North Carolina, United States PSC Biotech Full time

    Job DescriptionPSC Biotech is a leading provider of life sciences services, ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.The RoleWe are seeking an experienced Validation Project Manager to join our team. The successful candidate will have a strong technical background in...


  • Durham, North Carolina, United States PSC Biotech Full time

    About the RolePSC Biotech is seeking an experienced Validation Project Manager to join our team. As a key member of our validation team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key ResponsibilitiesDevelop and implement validation plans, protocols, and reports for...


  • Durham, North Carolina, United States PSC Biotech Corporation Full time

    About the RolePSC Biotech Corporation is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key ResponsibilitiesDevelop and implement validation plans, protocols, and...


  • Durham, North Carolina, United States PSC Biotech Full time

    PSC Biotech is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.Key responsibilities include:Developing and implementing validation plans, protocols, and reports for...


  • Durham, North Carolina, United States PSC Biotech Full time

    About PSC BiotechPSC Biotech is a leading provider of life sciences services, ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Job SummaryWe are seeking an experienced Validation Project Manager to join our team. The successful candidate will have a strong technical background...

  • Validation Specialist

    3 weeks ago


    Durham, North Carolina, United States Randstad Life Sciences US Full time

    Job Title: Validation EngineerWe are seeking a highly skilled Validation Engineer to join our team at Randstad Life Sciences US. As a Validation Engineer, you will play a critical role in ensuring the quality and compliance of our equipment and processes.Key Responsibilities:Perform and plan qualifications and associated processes to onboard, replace,...


  • Durham, North Carolina, United States PSC Biotech Full time

    Unlock Your Potential as a Validation Engineer at PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and regulatory compliance in the industry. We are seeking a skilled Validation Engineer to join our team and contribute to the success of our clients.As a Validation Engineer at PSC...


  • Durham, North Carolina, United States Novacares Full time

    Nova Biomedical is an Equal Opportunity Employer committed to diversity and inclusion in hiring and promoting women, minorities, veterans, and individuals with disabilities.Job Summary:As a Validation Support Specialist, you will provide field support in the Raleigh/Durham, North Carolina area to leading pharmaceutical and biotechnology companies. This role...


  • Durham, North Carolina, United States Novacares Full time

    Nova Biomedical is an Equal Opportunity Employer committed to diversity and inclusion in hiring and promoting women, minorities, veterans, and individuals with disabilities.Job Summary:We are seeking a highly skilled Validation Support Specialist to provide field support in the Raleigh/Durham, North Carolina area to leading pharmaceutical and biotechnology...

  • ETL Validation Tester

    2 weeks ago


    Durham, North Carolina, United States Pyramid Consulting, Inc Full time

    Job Title: ETL Validation TesterWe are seeking a talented ETL Validation Tester to join our team at Pyramid Consulting, Inc. This is a contract opportunity with long-term potential and is located in Durham, NC/Westlake, TX (onsite).Job Summary:The successful candidate will be responsible for implementing QA standard processes for data warehouse/data lake...


  • Durham, North Carolina, United States Pyramid Consulting, Inc Full time

    Job Title: ETL Validation TesterWe are seeking a talented ETL Validation Tester to join our team at Pyramid Consulting, Inc. This is a 12+ months contract opportunity with long-term potential and is located in Durham, NC/Westlake, TX (onsite).Job Summary:The successful candidate will be responsible for implementing QA standard processes for data...


  • Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full time

    Job Title: Senior Computer Systems Validation ConsultantWe are seeking a highly skilled Senior Computer Systems Validation Consultant to join our team at RCM Life Sciences and IT; RCM Technologies. As a key member of our team, you will be responsible for leading computer system validation projects related to authoring and executing specifications and...


  • Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full time

    Job Title: Senior Computer Systems Validation ConsultantRCM Life Sciences and IT;RCM Technologies is seeking a highly skilled Senior Computer Systems Validation Consultant to join our team. As a key member of our validation team, you will be responsible for leading computer system validation projects related to authoring and executing specifications and...


  • Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full time

    Job Title: Senior Computer Systems Validation ConsultantWe are seeking a highly skilled Senior Computer Systems Validation Consultant to join our team at RCM Life Sciences and IT; RCM Technologies. As a Senior Computer Systems Validation Consultant, you will be responsible for leading computer system validation projects related to authoring and executing...


  • Durham, North Carolina, United States RCM Life Sciences and IT;RCM Technologies Full time

    Job Title: Senior Computer Systems Validation ConsultantWe are seeking a highly skilled Senior Computer Systems Validation Consultant to join our team at RCM Life Sciences and IT;RCM Technologies. As a key member of our team, you will be responsible for leading computer system validation projects related to authoring and executing specifications and...


  • Durham, North Carolina, United States Novacares Full time

    Nova Biomedical is a leading medical device company seeking a skilled Validation Support Specialist to provide field support in the Raleigh/Durham area. This role offers a unique opportunity to grow with a market leader in the industry. Key responsibilities include providing installation, qualification, and operational qualification support on BioProfile...


  • Durham, North Carolina, United States ThermoFisher Scientific Full time

    Job DescriptionAt Thermo Fisher Scientific, we are seeking a highly skilled and experienced Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our raw material sampling and inspection processes.Key Responsibilities:Manage and maintain cleanrooms to meet...


  • Durham, North Carolina, United States WIRB-Copernicus Group Full time

    About WCGWCG is a leading provider of clinical solutions, built on a foundation of best-in-class clinical services companies. Our transformational solutions stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. We empower individuals on the frontlines of science and medicine, and the organizations striving to...