CQV Utilities Lead

The Lead C&Q Clean Utilities is accountable for all commissioning and qualification activities related to critical utility systems (e.g., purified water, WFI, clean steam, gases). They ensure systems are delivered according to GMP standards and project requirements.

Key Responsibilities:

• Develop and manage C&Q strategies, protocols, and schedules for clean utilities.
• Supervise execution of IQ/OQ/PQ testing for utility systems.
• Interface with engineering, construction, and quality teams.
• Ensure system documentation (URS, FS, DQ) is complete and accurate.
• Drive resolution of technical and quality issues.
• Validate system performance in compliance with regulatory requirements.
• Provide clear progress updates and elevate risks.

Qualifications:

• Bachelor’s degree in Engineering/Chemistry or equivalent.
• 7+ years C&Q or validation experience in clean utilities.
• Knowledge of industry standards (ISPE, FDA, GMP, etc.).