CQ Lead (Small molecule)

Role Overview:

The Commissioning & Qualification (CQ) Lead is responsible for overseeing and executing commissioning and qualification activities for pharmaceutical manufacturing facility projects, with an emphasis on small molecule operations. This role ensures all process systems, clean utilities, and equipment are delivered in compliance with regulatory requirements and industry standards, supporting both new builds and expansions.

Key Responsibilities:

• Develop and implement CQV strategies and execution plans for pharmaceutical manufacturing projects, with focus on small molecule operations.
• Lead commissioning and qualification activities for process systems, clean utilities (e.g., WFI, clean steam, compressed air), facility equipment, and related infrastructure.
• Author, review, and approve CQ documentation including commissioning plans, IQ/OQ/PQ protocols, summary reports, and risk assessments.
• Ensure all CQ activities comply with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory requirements.
• Collaborate with stakeholders, including Engineering, Quality Assurance, Operations, and third-party vendors throughout the project lifecycle.
• Support FAT, SAT, and startup activities for new systems and equipment.
• Lead, mentor, and coordinate CQV team members and contractors, ensuring timely delivery of project objectives.
• Manage resolution of CQ deviations, discrepancies, and non-conformances, implementing appropriate corrective actions.
• Provide technical support during regulatory audits and inspections relating to CQV scope.
• Maintain up-to-date knowledge of industry trends, guidance documents, and best practices relevant to pharmaceutical small molecule facility commissioning and qualification.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• Minimum 8+ years’ experience in commissioning and qualification within the pharmaceutical industry.
• Demonstrated expertise in small molecule pharmaceutical manufacturing and facility CQV requirements.
• Deep understanding of clean utility systems and process equipment used in small molecule production.
• Excellent knowledge of cGMP, FDA, EMA, ISPE guidelines and other relevant pharmaceutical regulations.