What are the responsibilities and job description for the Facilities Manager position at Gener8, LLC?
Job Title: | Regional Facilities Manager |
Reporting to: | Global Vice President, Operations |
Location: | San Jose, CA |
Job Site: | On-Site |
Job Description Revision Date: | March 2025 |
About us:
Since 2002, Gener8 has been a strategic partner in the life sciences and medical device industries, turning innovative concepts into market-ready realities. We provide comprehensive engineering design and manufacturing services for complex instruments, software, and consumables. Our team supports global innovators striving for breakthroughs in research, diagnostics, and surgical technology. With a specialized footprint spanning San Jose and Carlsbad, CA; Wilmington, MA; Indianapolis, IN; and San Jose, Costa Rica, Gener8 is uniquely positioned to deliver the precision and scale required by today’s medical professionals.
Summary:
The Regional Facilities Manager will oversee the operational maintenance, safety, and regulatory compliance of multiple manufacturing and engineering sites within the US. This role ensures that all physical infrastructure supports high-precision manufacturing, focusing on cleanroom integrity, environmental monitoring, and business continuity. You will provide a world-class environment for production, engineering, and administration.
Key Responsibilities:
- Regulatory Compliance & Environment:
- Maintain facilities in strict accordance with ISO 13485 and FDA standards.
- Oversee the certification and maintenance of Cleanrooms (ISO Class 7/8), ensuring HEPA filtration and pressure differentials meet validated specifications.
- Asset & Infrastructure Management:
- Implement a robust Preventative Maintenance (PM) program for critical utilities, including HVAC, compressed air, high-purity water systems (DI/RO), and backup power.
- Manage the Calibration of facility-related equipment to always ensure audit readiness.
- Strategic Operations:
- Manage the facilities budget (OpEx/CapEx), focusing on energy efficiency and cost reduction initiatives.
- Lead site(s) expansion or reductions projects, including office build-outs, production line transfers, and facility commissioning/decommissioning.
- Safety & Security (EHS):
- Act as the regional lead for Environmental Health and Safety (EHS), ensuring compliance with OSHA and local environmental regulations.
- Manage physical security protocols and emergency response planning for all regional sites.
- Vendor Management:
- Negotiate and oversee service-level agreements (SLAs) with third-party vendors for janitorial, landscaping, security, and specialized technical repairs.
Required Qualifications:
- Education: High-School degree.
- Experience: 10 years of experience in facilities management, with at least 3 years in a regulated manufacturing environment (MedTech, Pharma, Automotive or Aerospace).
- Technical Knowledge:
- Strong understanding of Building Management Systems (BMS) and CMMS software.
- Familiarity with FDA Quality System Regulations (QSR) regarding facility controls.
- Certifications: Certified Facility Manager (CFM) or FMP preferred.
- Soft Skills: Proven ability to lead remote teams and communicate complex technical issues to executive leadership.
Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.
We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration. |
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; pet insurance, STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Customer Referral Award, Employee Referral Award program.
Salary : $104,408 - $174,013