Position Overview
The C&Q Area Lead will orchestrate the commissioning, qualification, and validation of Grade C/D HVAC systems in GMP pharmaceutical manufacturing facilities. This role requires expertise in cleanroom environmental control, including ISO 14644 classification, pressure cascade management, and contamination control strategies. The candidate must demonstrate mastery of HVAC validation protocols, regulatory requirements for controlled environments, and risk-based approaches to system qualification.
Key Responsibilities
1. C&Q Strategy & Execution
• Develop ASTM E2500-aligned validation plans for HVAC systems, including HEPA filter integrity testing, airflow visualization studies, and non-viable particle monitoring.
• Execute DQ/IQ/OQ/PQ protocols for:
• Air Handling Units (AHUs): Fan performance curves, filter pressure drop validation, and thermal load capacity.
• Ductwork Systems: Airflow velocity uniformity (±15% design spec), leakage testing (≤0.5% total airflow).
• Control Systems: Client/EMS alarm testing (e.g., pressure differential alarms, temperature/humidity excursions).
2. Cleanroom Qualification
• Grade C/D Classification:
• Perform ISO 14644-1 particle counts (≥0.5μm and ≥5.0μm particles) under as-built, at-rest, and operational conditions.
• Validate air change rates (≥20 ACH for Grade C, ≥15 ACH for Grade D) and recovery time testing (≤15-20 minutes to ISO class).
• Pressure Cascade: Verify differential pressure gradients (≥10-15 Pa between zones) and fail-safe operation during door openings.
3. Risk-Based Environmental Control
• Conduct FMEA for HVAC system failure modes impacting product quality (e.g., loss of pressure differential, filter bypass).
• Qualify backup systems: Emergency power supply (UPS/generators) for AHUs and redundancy protocols.
4. Documentation & Compliance
• Author protocols/reports for:
• HEPA Filter Certification: PAO/DOP leak testing (≤0.01% penetration per IEST RP-CC034).
• Smoke Studies: Unidirectional airflow validation (Grade C) using fog generators.
• Temperature/Humidity Mapping: Data loggers placed per ISPE guidelines (≥20 sensors per zone).
• Ensure compliance with EU GMP Annex 1, FDA 21 CFR Part 211.46, and ISO 14698 bio contamination standards.
5. Technical Leadership
• Lead Client/EMS integration for real-time monitoring of critical HVAC parameters (pressure, airflow, particulates).
• Collaborate with Automation to qualify alarm hierarchies and data integrity per 21 CFR Part 11.
• Mentor junior engineers on thermoanemometry, particle counter calibration, and cleanroom gowning protocols.
Qualifications
• Education: BS/MS in Mechanical Engineering or Building Services Engineering.
• Experience:
• 8+ years in HVAC C&Q for pharma/biotech Grade C/D environments.
• Technical Skills:
• Proficiency in Kneat, ValGenesis, or Blue Mountain RAM for electronic validation workflows.
• Expertise in ISO 14644 classification testing and IEST standards for cleanroom operations.
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