Facilities/Utilities/HVAC Lead
Job in
New Brunswick, Middlesex County, New Jersey, 08933, USA
Listed on 2025-12-01
Listing for:
Pharmatek Consulting Inc.
Full Time
position Listed on 2025-12-01
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Pharma Engineer, Biomedical Engineer
Job Description & How to Apply Below
New Brunswick, United States | Posted on 10/02/2024
- Industry Pharma/Biotech/Clinical Research
- Job Type Contract
- Work Experience 5+ years
- State/Province New Jersey
- Country United States
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.
Key Responsibilities- 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).
- Conduct risk assessments and develop mitigation strategies for potential compliance issues.
- Provide cross-functional support and expertise to other CQV activities asneeded.
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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