Facilities/Utilities/HVAC Lead - 1

Seeking a CQV Lead specializing in facilities and engineering to oversee the qualification of building utilities, clean utilities, and environmental systems. This individual will be responsible for developing and executing commissioning, qualification, and validation (CQV) protocols to ensure regulatory compliance and to ensure traceability to design requirements.

• Lead CQV efforts for facilities and utilities, including HVAC, water systems, and building automation.

• Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems.

• Collaborate with engineering and project teams to align validation activities with construction schedules.

• Ensure all validation documentation complies with regulatory standards (FDA, cGMP).

• Validation master planning

• Conduct risk assessments and develop mitigation strategies for potential compliance issues.

• Provide cross-functional support and expertise to other CQV activities as needed.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.

• 10+ years of experience in CQV roles within pharmaceutical or biotech industries.

• Expertise in facilities, utilities, and building management systems (BMS).

• Strong understanding of FDA regulations and cGMP requirements.