Chief Engineer Job at MalaceHR, San Jose, CA

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  • MalaceHR
  • San Jose, CA

Job Description

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 Dickinson’s life-sciences mission.

Key Responsibilities

Facility Operations & Maintenance

  • 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.

Hands-On Technical Work

  • 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.

Regulatory Compliance

  • 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.

Team Leadership

  • 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.

Emergency & Critical Operations

  • Participate in 24/7 on-call rotation.

  • Rapidly respond to HVAC, utility, water, or power disruptions.

  • Ensure backup systems readiness and maintain incident documentation.

Required Qualifications

Education & Experience

  • Bachelor’s 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 Certifications

  • 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.

Industry Expertise

  • 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.

Leadership Experience

  • Prior experience leading multi-disciplinary maintenance teams.

  • Vendor management and project oversight strongly preferred.

Working Conditions

  • Physically demanding environment: lifting up to 50 lbs, ladders, confined spaces, PPE use.

  • Monday–Friday 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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