Impel Talent is leading a confidential search for a CQV Engineer for a globally recognized company in the pharmaceutical manufacturing sector. This international, family-owned company is renowned for its innovative technological capabilities and strong market presence. The company’s success is driven by a dedicated, diverse team of professionals across multiple global locations.
The CQV Engineer will be a key member of the Global Engineering team, supporting
pharmaceutical manufacturing projects through the full lifecycle of commissioning,
qualification, and validation. The focus is on ensuring that equipment and systems meet GMP
and regulatory standards from design through startup and operation.
Responsibilities:
• Lead and execute commissioning and qualification (C&Q) activities for pharmaceutical systems and equipment, including FAT, SAT, IQ, OQ, and PQ.
• Draft and execute validation protocols, test plans, and traceability matrices in compliance with GMP standards.
• Ensure systems meet user requirements and regulatory expectations (GAMP5, EU/FDA).
• Review and approve technical documentation, design specifications, and user requirement specifications
• Troubleshoot equipment and support start-up activities in collaboration with automation, process, and engineering teams.
• Liaise with QA to ensure validation documentation meets compliance and inspection readiness.
• Participate in cross-functional teams for equipment integration and system handovers.
Qualifications:
• Bachelor’s degree in Engineering or related discipline.
• 5–10 years of relevant experience in commissioning and validation in pharma, biotech, or similarly regulated industries.
• Strong understanding of GMP, GEP, and CSV requirements.
• Field experience in startup and validation of automated and process equipment.
• Excellent English communication skills (written and verbal).