Senior HVAC Maintenance Technician, GMP & Cleanroom Systems
Overview
You will own preventive, predictive, and corrective maintenance across AHUs, chillers, boilers, heat exchangers, VAVs, exhaust, dehumidifiers, and split systems, ensuring temperature, humidity, airflow, and pressurization in GMP spaces. You will ensure cleanroom compliance with ISO 14644, including HEPA integrity, airflow patterns, recovery times, and differential pressures, and support aseptic areas and gowning zones. You will optimize and troubleshoot BMS/EMS/SCADA systems (Siemens, Allen-Bradley, Johnson Controls), tune PID loops, and document changes via change control. You will coordinate calibration and support IQ/OQ/PQ with solid validation documentation. You will drive investigations and CAPA using 5-Why and Fishbone, maintaining impeccable cGMP/GDP records. You will champion audit readiness (FDA/EU) and improve energy performance with VFDs and smart controls. You will lead safety culture (LOTO, confined space, arc-flash, EPA 608) and mentor junior techs. What makes this role different: you are the subject matter expert for mission-critical pharmaceutical environments, with direct impact on compliant manufacturing and product quality.
What You'll Do10
- 1Lead preventive, predictive, and corrective maintenance on AHUs, chillers, boilers, heat exchangers, VAVs, exhaust, dehumidifiers, and split systems to ensure GMP compliance.
- 2Ensure cleanrooms meet ISO 14644 standards: verify HEPA integrity, airflow patterns, recovery times, and differential pressures in aseptic areas.
- 3Optimize and troubleshoot BMS/EMS/SCADA (Siemens, Allen-Bradley, Johnson Controls): tune PID loops, rationalize alarms, adjust sequences, and document via change control.
- 4Coordinate calibration of temperature, RH, pressure, and flow sensors, and support IQ/OQ/PQ with accurate validation documentation.
- 5Drive investigations and CAPA using 5-Why and Fishbone root cause analysis, and maintain impeccable cGMP and GDP records and SOPs.
- 6Champion audit readiness for FDA and EU GMP inspections, keeping systems in a validated state at all times.
- 7Improve energy and performance: implement VFDs, heat recovery, demand-based ventilation, and smart control strategies.
- 8Plan and execute outages, turnarounds, and capital projects with contractors, materials, and risk assessments.
- 9Lead safety culture: enforce LOTO, confined space, hot work, arc-flash, and EPA 608 refrigerant handling; mentor junior technicians.
- 10Manage spare parts and CMMS workflows, and partner with Quality, Manufacturing, Engineering, Validation, and Operations.
Requirements10
- 16-10+ years in HVAC maintenance, including 3-5 years in pharma/biotech or regulated GMP environments.
- 2Technical diploma or apprenticeship in HVAC/Mechanical/Building Services; bachelor's in Mechanical/Building is a plus.
- 3Strong proficiency in AHUs, chillers, boilers, hydronics, humidity control, and HEPA filtration.
- 4Advanced BMS/controls skills: PID tuning, trend analysis, data integrity, and sequence of operation.
- 5Knowledge of ISO cleanroom classifications, airflow visualization/smoke studies, pressurization cascades, and aseptic requirements.
- 6Experience with sensor calibration, IQ/OQ/PQ, GDP, CAPA, and change control.
- 7Diagnostic skills: advanced troubleshooting, basics of vibration analysis and thermography; use of anemometers, micromanometers, particle counters, and data loggers.
- 8Preferred certifications: safety training (e.g., LOTO, confined space), manufacturer training on chillers/controls, and GxP/cleanroom courses.
- 9Physical ability: lift 50 lbs, work from ladders/heights/mechanical spaces, use PPE in labs/cleanrooms, and participate in on-call rotation.
- 10Clear communication, teamwork, stakeholder management, decisive under time pressure, and meticulous documentation.
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