What are the responsibilities and job description for the Regional (US) 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. Minimal travel will be required.
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.
Why Join Us?
We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives.
Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.
Message to applicants:
The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.
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Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Salary : $104,408 - $174,013