What are the responsibilities and job description for the Commissioning & Qualification Lead - HVAC position at Warman O’Brien?
C&Q Area Lead – HVAC
Warman O’Brien is delighted to partner with a Leading Pharmaceutical Company seeking an experienced C&Q Area Lead to support the commissioning, qualification, and validation (CQV) of Grade C/D HVAC systems in a GMP pharmaceutical manufacturing facility. This is a long-term, 12-month extendable project.
Responsibilities:
- Develop and execute ASTM E2500-aligned validation plans for HVAC systems, including HEPA filter integrity testing, airflow visualization, and particle monitoring.
- Lead DQ/IQ/OQ/PQ for Air Handling Units (AHUs), ductwork systems, and environmental control systems.
- Perform ISO 14644 cleanroom classification, pressure cascade verification, and air change rate validation.
- Conduct risk assessments (FMEA) to mitigate HVAC system failures impacting product quality.
- Ensure compliance with EU GMP Annex 1, FDA 21 CFR Part 211.46, and ISO 14698 bio-contamination standards.
Experience & Skills:
- 8 years of HVAC C&Q experience in pharmaceutical or biotech Grade C/D environments.
- Strong expertise in ISO 14644 classification, IEST cleanroom operations, and environmental monitoring.
- Proficiency with Kneat, ValGenesis, or Blue Mountain RAM for electronic validation workflows.
1099 Contract
Competitive Hourly Rate
Full time onsite - 40 hours per week
Start Date - April/May 2025
If you would like to be considered, please apply now to arrange for a confidential discussion with one of our recruiters!
