Senior Maintenance Technician
Synectics
Position Summary:
- Working Hours: Monday-Friday (11am-7:30pm)
- The Senior Maintenance HVAC Technician is responsible for ensuring reliable, compliant, and efficient operation of HVAC and environmental control systems for GMP facilities
- This role leads complex maintenance and troubleshooting activities for cleanrooms, laboratories, and production areas; manages critical utilities that impact product quality; and drives continuous improvement initiatives aligned with regulatory standards such as FDA, & EU GMP Standards.
- The technician serves as a subject matter expert for HVAC, Building Management Systems (BMS)/SCADA, Cleanroom Pressurization, Temperature/Humidity Control, HEPA Filtration, and Environmental Monitoring, mentoring junior technicians and collaborating closely with Quality, Engineering, EHS, and Operations. Overall, the role focuses on maintaining all HVAC System to control temperature, humidity, differential pressure, and air quality to protect product quality, personnel safety, and regulatory compliance.
- HVAC Operations & Reliability: Perform preventive, predictive, and corrective maintenance on air handlers, chillers, boilers, heat exchangers, VAVs, exhaust systems, dehumidifiers, and split systems to maintain controlled temperature, humidity, airflow, and pressurization in GMP spaces.
- Cleanroom & GMP Compliance: Maintain environmental conditions per ISO 14644 classifications and facility SOPs; ensure proper HEPA filter integrity, airflow patterns, recovery times, and differential pressures; support gowning airlocks and aseptic areas.
- BMS/EMS/SCADA Management: Monitor, tune, and troubleshoot Building Management Systems and Environmental Monitoring Systems; implement setpoint strategies, alarm rationalization, and sequence-of-operations adjustments; document changes per change-control.
- Calibration & Qualification Support: Coordinate and perform periodic calibration of sensors (temperature, RH, pressure, flow) and support HVAC system IQ/OQ/PQ activities; generate and review qualification protocols and reports.
- Troubleshooting & Root Cause Analysis: Lead investigations of deviations, alarms, and environmental excursions; apply RCA methods (5-Why, Fishbone) and implement robust corrective and preventive actions (CAPA).
- Documentation & GMP Records: Complete accurate work orders, maintenance logs, and calibration records; author and revise SOPs, job plans, and standard work; maintain asset history compliant with cGMP and GDP requirements.
- Regulatory & Audit Readiness: Support internal and external audits (e.g., FDA, Internal); provide evidence of maintenance, calibration, and qualification; ensure systems remain in validated state and changes follow formal Change Control.
- Energy & Performance Optimization: Analyze HVAC performance, energy consumption, and lifecycle costs; recommend upgrades (VFDs, control strategies, heat recovery, demand-based ventilation) to improve reliability and sustainability.
- Project & Shutdown Execution: Plan and execute HVAC outages, turnarounds, and capital projects; coordinate contractors, materials, risk assessments, and schedules to minimize impact on operations.
- EHS & Safety Leadership: Ensure work follows LOTO, confined space, hot work, and arc-flash procedures; conduct Job Hazard Analyses (JHA); handle refrigerants per EPA Section 608; champion a strong safety culture.
- Mentoring & Training: Coach junior technicians on GMP expectations, diagnostics, and SOP adherence; deliver training on BMS operation, cleanroom behavior, and maintenance best practices.
- Spare Parts & CMMS: Manage critical spares and inventory; use CMMS to plan, prioritize, and close work orders; contribute to asset hierarchy and preventive maintenance optimization.
- Cross-Functional Collaboration: Partner with Quality, Manufacturing, Facilities Engineering, and Validation to align HVAC performance with product/process needs and to respond rapidly to excursions.
- Technical Diploma/apprenticeship in HVAC, Mechanical, or Building Services or completion of an accredited HVAC trade/apprenticeship program
- Mechanical/Building Bachelor's degree is a plus.
- 6-10+ years of progressively responsible HVAC maintenance experience, with at least 3-5 years in pharmaceutical, biotech, or other regulated GMP environments; cleanroom HVAC experience is essential.
- HVAC Systems: Strong expertise in AHUs, chillers, boilers, hydronic systems, HVAC zoning systems, exhaust and make-up air, humidity control, and HEPA filtration.
- Controls/BMS: Proficiency with BMS platforms (e.g., Siemens, AB, Johnson Controls), knowledge of PID tuning, sequences of operation, alarms, trending, and data integrity practices.
- Cleanroom & GMP: Deep understanding of ISO Cleanroom Classification, airflow visualization/smoke studies, pressurization cascades, and aseptic environmental requirements.
- Calibration/Qualification: Experience with sensor calibration, IQ/OQ/PQ, and validation documentation; familiarity with GDP, CAPA, and Change Control.
- Diagnostics: Advanced troubleshooting, vibration analysis basics, thermography, and use of instrumentation (anemometers, micromanometers, particle counters, data loggers).
- Certifications: Safety training preferred; manufacturer training on chillers/controls and GxP/cleanroom courses are advantageous.
- Soft Skills: Strong communication, teamwork, and stakeholder management; ability to prioritize in a manufacturing environment, make decisions under time pressure, and document meticulously.
- Physical & Work Requirements: Ability to lift 50 lbs, climb ladders, work in mechanical spaces and at heights, respond to after-hours calls/on-call rotation, and use PPE appropriate to labs/cleanrooms.
- Experience with manufacturing equipment is acceptable, especially if they are looking to move into facility roles.
- Relevant job titles can include HVAC Technician, Facilities Engineer, Chief Engineer, On-Site Engineer, Senior Maintenance Technician, or Manufacturing Technician with progressive facilities/maintenance experience.
Vacancy posted 1 day ago
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