Commissioning & Qualification Lead
Company Overview
PQE Group is a women-owned, ISO-certified technology solutions and compliance consulting company serving the Life Sciences industry. With 2,000+ employees across 40+ offices worldwide, we deliver quality, compliance, and process optimization for global clients.
Job Summary
Lead and execute Commissioning & Qualification (CQV) activities for pharmaceutical and biotech projects, ensuring compliance with cGMP and regulatory standards while coordinating cross-functional teams and managing project risks and milestones.
Responsibilities
- Lead CQV execution for assigned systems and process areas to ensure timely and compliant project delivery
- Develop comprehensive CQV strategies, execution plans, and supporting procedures aligned with project goals
- Coordinate commissioning activities across Engineering, Operations, QA, EHS, Automation, and external vendors to ensure seamless integration
- Review and approve CQV protocols, test scripts, deviations, and change controls to maintain quality and compliance
- Support Mechanical Completion, construction walkdowns, and system handovers to facilitate smooth project transitions
- Ensure adherence to cGMP, regulatory requirements, and company quality standards throughout CQV processes
- Report progress, milestones, risks, and issues to project leadership to enable informed decision-making
Required competencies and certifications
- Bachelor’s degree in Chemical, Mechanical, Process Engineering, or related engineering discipline
- Minimum 10 years of CQV experience in pharmaceutical or biotechnology industries
- Proven experience leading CQV field execution on large capital projects
- Strong knowledge of cGMP and Risk-Based Validation principles
- PMP certification or equivalent project management qualification
Preferred competencies and qualifications
- Experience in HVAC & Cleanrooms systems
- Experience in Drug Linker / API Manufacturing processes
- Experience in Thermal Mapping techniques
- Experience with Laboratory & Analytical Systems
- Professional proficiency in English
- Excellent communication and stakeholder management skills