Validation Engineering Specialist
Location: London
Industry: Biotechnology
Recruiter: Cpl Life Sciences
Cpl Life Sciences is currently recruiting for a Validation Engineering Specialist to join a leading biotechnology company based in London. This position will support the Engineering Validation team across GxP-regulated processes, equipment, facilities, and computerised systems (CSV). The successful candidate will ensure validation activities are executed in compliance with EU, UK, and FDA regulatory requirements and Good Manufacturing Practice (GMP) standards.
Key Responsibilities:
Oversee validation and CSV activities, ensuring full compliance with applicable EU/UK/FDA and GMP regulations.
Review and approve qualification protocols, reports, and discrepancies; escalate concerns to management as needed.
Review and approve Standard Operating Procedures (SOPs).
Collaborate cross-functionally with QA, Laboratory, Operations, and Warehouse teams to align on project timelines and deliverables.
Serve as the Subject Matter Expert (SME) for validation compliance during audits and regulatory inspections, and lead on any required follow-up actions.
Prepare and manage GMP documentation, including CAPAs, change controls, and other quality records.
Maintain up-to-date training records and ensure timely completion of mandatory training modules.
Candidate Requirements:
Degree (or equivalent) in Life Sciences or a related discipline.
Minimum of 5 years' experience in Engineering Validation, including exposure to Computerised Systems Validation (CSV).
In-depth understanding of GxP regulations and compliance frameworks.
Previous experience interacting with regulatory authorities is desirable.
Professional, collaborative, and able to perform effectively under pressure in a fast-paced environment.