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