Chief Engineer
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Job Location:
San Jose, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 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
Bachelors 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.
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.
Key Skills
- Mold Remediation
- Succession Planning
- Employee Evaluation
- Basic Math
- Host/Hostess Experience
- Restoration
- Restoration Industry Experience
- Water Damage Restoration
- Emergency Management
- Auto Restoration
- Fire Restoration
- Financial Report Interpretation
