Chief EngineerMalaceHR • San Jose, CA, United States

Chief Engineer

MalaceHR • San Jose, CA, United States

8 hours ago

Job type

Full-time

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 hands‑on leadership role combines 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.

Respond rapidly 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 a 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 multidisciplinary 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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Chief Engineer • San Jose, CA, United States

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