Proclinical is on the hunt for a bold, innovative thinker who is ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a CQV Lead to oversee the delivery of pharmaceutical facility and equipment projects. In this role, you will ensure systems are commissioned and qualified in compliance with GMP and regulatory standards. This position involves collaboration with cross-functional teams, vendor management, and leadership in executing validation protocols.
Key responsibilities:
- Collaborate with engineering and project teams to integrate CQV requirements during the design phase.
- Review P&IDs, URS, and design specifications for GMP compliance and validation readiness.
- Manage vendor selection, technical reviews, FAT/SAT activities, and ensure timely delivery of equipment and documentation.
- Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems.
- Align activities with validation master plans and regulatory expectations (FDA, EMA, MHRA).
- Maintain accurate records, including change controls, deviations, and validation reports.
- Ensure all activities comply with GMP, GEP, and data integrity standards.
- Lead cross-functional teams, including engineering, QA, manufacturing, and external contractors.
- Drive project delivery, troubleshoot issues, and ensure milestones are achieved on time and within budget.
Skills & Requirements:
- Background in Engineering, Life Sciences, or a related discipline.
- Strong understanding of GMP validation principles and regulatory frameworks.
- Experience managing vendors, contracts, and complex technical projects.
- Excellent communication, negotiation, and stakeholder management skills.
- Familiarity with sterile manufacturing, biologics, or high-potency APIs is a plus.
- Knowledge of automation systems and digital validation tools is advantageous.
- Exposure to global or multi-site operations is preferred.
If you are having difficulty in applying or if you have any questions, please contact Jordan Kiely at j.kiely@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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