CQV Clean Utilities Lead

The CQV Clean Utilities Lead is responsible for the planning, execution, and documentation of commissioning, qualification, and validation activities related to clean utility systems (e.g., WFI, Purified Water, Clean Steam, Compressed Gas, etc.) in pharmaceutical, biotechnology, and related facilities. This individual ensures that all systems are delivered in accordance with regulatory requirements, project specifications, and industry standards.

Key Responsibilities:

• Lead CQV efforts for clean utility systems, ensuring compliance with cGMP, FDA, EU, and other relevant regulations and guidelines.
• Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for clean utilities such as Water for Injection (WFI), Purified Water, Clean Steam, Process Gases, etc.
• Coordinate and oversee the preparation, testing, and documentation requirements for all clean utilities.
• Collaborate with engineering, construction, QA/QC, and operations teams to ensure proper installation, verification, and handover of utility systems.
• Manage and monitor the implementation of systems from design through start-up and qualification.
• Review and approve design documentation, technical specifications, and vendor-supplied documentation.
• Prepare and review risk assessments, user requirements specifications (URS), and functional specifications.
• Support root cause analysis, deviations, and change control processes for clean utility systems.
• Lead troubleshooting and resolution processes during commissioning and qualification activities.
• Maintain accurate records and reports for CQV activities and participate in audits and regulatory inspections.
• Ensure project timelines and deliverables are met for clean utilities CQV activities.
• Train, mentor, and supervise junior CQV staff, as needed.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• Minimum 8 years of experience in CQV of clean utility systems within pharmaceutical or biotech industries.
• In-depth knowledge of clean utility systems and relevant regulatory requirements (FDA, GMP, EU Annexes).
• Experience with validation protocols, technical documentation, and change control systems.
• Strong project management and organizational skills.
• Excellent written and verbal communication abilities.
• Ability to work both independently and as part of a multidisciplinary team.

Preferred Skills:

• Experience with large-scale capital projects and multi-system integration.
• Familiarity with computerized system validation.
• Vendor and contractor management experience.
• Professional certifications (e.g., ISPE, ASQ) are an advantage.