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