CQV Validation Lead – Biologics GMP Restart

Barrington James; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Barrington James is seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This role involves leading CQV activities for process equipment and ensuring compliance with GMP standards.

Ideal candidates will have 5-7 years of experience in validation, particularly within pharma or biotech sectors. Strong technical writing and an understanding of Annex 11 requirements are necessary. This position offers a dynamic and project-driven work environment.

Qualifications

• 5–7 years’ experience in CQV / Validation within pharma / biotech / biologics.
• Proven experience supporting GMP manufacturing environments.
• Hands-on experience with upstream and/or downstream processing systems.
• Strong knowledge of validation lifecycle and documentation standards.
• Experience with Annex 11 / CSV (Computer System Validation).

Responsibilities

• Lead and execute CQV activities for process equipment, utilities, and systems.
• Support GMP restart/remediation efforts, ensuring systems are inspection-ready.
• Develop and review validation lifecycle documentation.
• Ensure compliance with GMP standards and EU Annex 11 requirements.
• Collaborate cross-functionally with QA, Manufacturing, Engineering, and MSAT teams.
• Support technology transfer activities, including process and equipment handover.
• Drive and support risk assessments and deviation investigations.
• Ensure strong data integrity and documentation practices.
• Participate in commissioning and qualification testing execution.

Skills

Technical writing and documentation

GMP regulations knowledge

Technology transfer processes

Stakeholder engagement

Cross-functional collaboration

Job description

Barrington James is seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This role involves leading CQV activities for process equipment and ensuring compliance with GMP standards.

Ideal candidates will have 5-7 years of experience in validation, particularly within pharma or biotech sectors. Strong technical writing and an understanding of Annex 11 requirements are necessary. This position offers a dynamic and project-driven work environment.