Facilities/Utilities/HVAC Lead - 1
$93,600,000–$104,000,000 year
On-siteNew Brunswick, Canada
Job Summary
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 while ensuring all validation documentation complies with FDA and cGMP regulatory standards. Collaborate with engineering and project teams to align validation activities with construction schedules, conduct risk assessments, and develop mitigation strategies for potential compliance issues. Provide cross-functional support and expertise to other CQV activities as needed. This role focuses on maintaining traceability to design requirements within pharmaceutical or biotech industries.
Required Qualifications
- 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
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