Summary Sheet: Trades & Services |
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| Advertiser Name | Warman OBrien | | Advertiser Type: | Agency |
| Classification: | Trades & Services | | Subclassification: | |
| Country: | United States | | Location: | United States |
| Language: | English - United Kingdom (en-GB) | | Contact Name: | |
| Employment Type: | Permanent | | Workhours: | Full Time |
Position: Commissioning & Qualification Lead - HVAC |
Description:
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!
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