MalaceHR is seeking a highly skilled Chief Engineer to lead all facility operations, maintenance, and compliance for a critical pharmaceutical manufacturing and laboratory environment. This is a hands-on leadership role , combining technical expertise with strategic facility management. The Chief Engineer ensures 24/7 facility reliability, GxP compliance, and operational excellence while supporting Becton Dickinsonâs life-sciences mission.
Oversee and execute preventive maintenance for HVAC, electrical, plumbing, compressed air, water systems, and critical utilities.
Maintain detailed SOPs, documentation, and compliance records required for FDA-regulated operations.
Coordinate maintenance with BD operations to minimize production impact.
Manage budgets, vendors, and facility improvement projects.
Perform troubleshooting, repairs, and complex maintenance on chillers, boilers, AHUs, electrical distribution systems, and specialty pharma equipment.
Lead emergency response for system failures and critical events.
Conduct calibrations, system validations, and routine maintenance to meet pharmaceutical standards.
Ensure compliance with FDA, cGMP, and GxP requirements.
Support validation activities, change control, CAPA processes, and regulatory audits.
Maintain documentation and participate in inspection preparation and response.
Lead and mentor maintenance technicians and oversee third-party vendors.
Establish safety standards, maintenance procedures, and training programs.
Drive continuous improvement in reliability and compliance.
Participate in 24/7 on-call rotation.
Rapidly respond to HVAC, utility, water, or power disruptions.
Ensure backup systems readiness and maintain incident documentation.
Bachelorâs degree in Mechanical/Electrical Engineering, Facilities Management, or related field.
8+ years of progressive facilities experience, with at least 5 years in pharmaceutical, biotech, or other FDA-regulated environments.
HVAC : NATE or equivalent required.
Electrical : State electrical license or equivalent; NEC knowledge; arc-flash/electrical safety training.
Safety : OSHA 30, First Aid/CPR, LOTO; confined space certification preferred.
CFM or similar credential is a plus.
Strong working knowledge of cGMP, GLP, GCP, and FDA 21 CFR Part 210/211.
Experience with validated systems, change control, CAPA, and deviation investigations.
Proficiency with BAS, CMMS, UPS systems, generators, WFI, compressed gases, environmental monitoring, and pharmaceutical-grade HVAC.
Prior experience leading multi-disciplinary maintenance teams.
Vendor management and project oversight strongly preferred.
Physically demanding environment: lifting up to 50 lbs, ladders, confined spaces, PPE use.
MondayâFriday schedule with required overtime based on operations.
On-call rotation (24/7) approximately once per month; 30-minute response time required.
Work involves labs, manufacturing areas, rooftops, and mechanical spaces.
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