Demo

Chief Engineer

MalaceHR
San Jose, CA Full Time
POSTED ON 11/25/2025
AVAILABLE BEFORE 1/24/2026
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 Dickinsons life-sciences mission.Key ResponsibilitiesFacility Operations & MaintenanceOversee 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.Hands-On Technical WorkPerform 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.Regulatory ComplianceEnsure 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.Team LeadershipLead and mentor maintenance technicians and oversee third-party vendors.Establish safety standards, maintenance procedures, and training programs.Drive continuous improvement in reliability and compliance.Emergency & Critical OperationsParticipate in 24/7 on-call rotation.Rapidly respond to HVAC, utility, water, or power disruptions.Ensure backup systems readiness and maintain incident documentation.Required QualificationsEducation & ExperienceBachelors 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.Technical CertificationsHVAC: 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.Industry ExpertiseStrong 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.Leadership ExperiencePrior experience leading multi-disciplinary maintenance teams.Vendor management and project oversight strongly preferred.Working ConditionsPhysically demanding environment: lifting up to 50 lbs, ladders, confined spaces, PPE use.MondayFriday 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.

Salary : $141,000 - $176,000

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