Validation Engineer

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

We are seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This role will focus on commissioning, qualification, and validation activities across upstream and downstream processing systems, ensuring compliance with regulatory standards.

This is an excellent opportunity to work on a high-impact project involving technology transfer, documentation, and compliance (including Annex 11) in a fast-paced, regulated setting.

Key Responsibilities

• Lead and execute CQV activities for process equipment, utilities, and systems within a biologics facility
• Support GMP restart/remediation efforts, ensuring systems are inspection-ready
• Develop and review validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, protocols, and reports)
• 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 (e.g., FMEA) and deviation investigations
• Ensure strong data integrity and documentation practices
• Participate in commissioning and qualification testing execution

Required Experience

• 5–7 years’ experience in CQV / Validation within pharma / biotech / biologics
• Proven experience supporting GMP manufacturing environments, ideally with facility restart, remediation, or start-up projects
• 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)

Key Skills

• Strong technical writing and documentation skills
• Solid understanding of GMP regulations and compliance frameworks
• Experience with technology transfer processes
• Excellent stakeholder engagement and cross-functional collaboration
• Ability to work in a fast-paced, project-driven environment