Freelance CQV Engineer

Location: Lyon, FranceDuration: 12-Month ContractIndustry: PharmaceuticalsContract Type: Freelance / Consultant

Freelance CQV Engineer

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.