Freelance CQV Engineer

EPM Scientific; Lyon; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

The Freelance CQV Engineer role in Lyon, France, is for a capital project at a pharmaceutical facility. The consultant will deliver commissioning, qualification and validation activities across GMP utilities, equipment, process systems and supporting infrastructure, ensuring regulatory and project compliance.

Responsibilities include developing qualification documentation (DQ/IQ/OQ/PQ, risk assessments, traceability matrices, protocols) and coordinating field execution with Engineering,

Qualifications

• Minimum 5 years delivering CQV in GMP pharma/biotech environments.
• Knowledge of ISPE Guidance and EU GMP Annex 1.
• Experience executing IQ, OQ and PQ protocols.
• Ability to review engineering docs and P&IDs.
• Strong cross-functional collaboration and stakeholder management.

Responsabilités

• Execute CQV activities per project schedules and GMP requirements.
• Develop and review qualification docs (DQ/IQ/OQ/PQ, risk assessments, protocols, traceability matrices, reports).
• Coordinate field execution with Engineering, Operations, QA and vendors.
• Support FAT and SAT activities as needed.
• Review P&IDs, specs, datasheets and vendor docs.
• Turnover activities from construction through commissioning to operations.
• Collaborate with QA to ensure system release.
• Provide regular updates to CQV Lead and Project Management.

Connaissances

CQV activities

ISPE Guidance

EU GMP

Annex 1

IQ/OQ/PQ protocols

Description du poste

Location: Lyon, France
Duration: 12-Month Contract
Industry: Pharmaceuticals
Contract 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.