Commissioning & Qualification Lead - HVAC

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

Full Time