Freelance CQV Engineer
Freelance CQV Engineer
Location: Lyon, France
Duration: 12-Month Contract
Industry: Pharmaceuticals
Contract Type: Freelance / Consultant
Overview
Our pharmaceutical client is seeking an experienced CQV Engineer to support a capital project at their manufacturing facility in Lyon. The successful consultant will be responsible for delivering Commissioning, Qualification and Validation activities across a range of GMP utilities, equipment, process systems and supporting infrastructure, ensuring compliance with regulatory and project requirements.
Responsibilities
- Execute Commissioning, Qualification and Validation (CQV) activities in accordance with project schedules and GMP requirements.
- Develop and review qualification documentation including:
- Commissioning Protocols
- Risk Assessments
- DQ, IQ, OQ and PQ Protocols
- Traceability Matrices
- Summary Reports
- Coordinate field execution of qualification activities with Engineering, Operations, Quality and external vendors.
- Support FAT and SAT activities where required.
- Perform GMP impact assessments and system boundary reviews.
- Manage deviation investigations and support corrective actions related to qualification activities.
- Ensure GDP and GMP compliance throughout all documentation and testing activities.
- Participate in system walkdowns and mechanical completion verification.
- Review engineering documentation including P&IDs, specifications, datasheets and vendor documentation.
- Support turnover activities from construction through commissioning and qualification to operations.
- Collaborate with Quality Assurance to ensure successful system release.
- Provide regular project updates to CQV Lead and Project Management teams.
Requirements
- Minimum 5 years' experience delivering CQV activities within GMP-regulated pharmaceutical or biotech environments.
- Strong knowledge of:
- ISPE Guidance
- EU GMP Requirements
- Annex 1
- Commissioning and Qualification methodologies
- Experience executing IQ, OQ and PQ protocols.
- Proven track record supporting large-scale pharmaceutical manufacturing projects.
- Ability to review and interpret engineering documentation and P&IDs.
- Experience working in cross-functional project teams.
- Excellent communication and stakeholder management skills.
If the opportunity sounds interesting, please click the relevant links to apply.
Alternatively, if you know of anyone who would be suitable, feel free to share this advert with them.
Looking forward to hearing from you.
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