Head of Facilities (Sr. Manager) - Medical Device/Pharma presso Vivani Medical, Inc
Vivani Medical, Inc · Alameda, Stati Uniti d'America · On-site
- Ufficio in Alameda
Description
We are seeking an accomplished Head of Facilities to lead site-level operations and ensure the reliable performance, maintenance, and compliance of all facility systems. This role is critical to supporting a GMP-regulated environment and upholding the highest standards in EHS, quality, and operational excellence.
The ideal candidate brings deep experience in medical device or pharmaceutical facilities management, thrives in a fast‑paced, small company, cross‑functional setting, and is a proactive, solutions‑oriented leader capable of navigating diverse challenges with independence and confidence.
Key Responsibilities
- Provide strategic and hands-on leadership for all day‑to‑day facilities operations, serving as the primary point of contact for the site and satellite facility.
- Partner across departments to troubleshoot and resolve facilities and maintenance issues that impact operational activities.
- Lead and mentor the facilities team, ensuring successful execution of multiple projects with varying complexity, timelines, and resource needs.
- Respond to off‑hours emergencies and communicate effectively with leadership during critical situations.
- Coordinate and oversee facility projects and provide technical expertise in electrical, process piping, HVAC, refrigeration, and related systems.
- Support facility construction, renovation, and expansion activities, coordinating with internal teams, architects, engineers, and contractors; assisting with project planning, scheduling, and budget tracking; and ensuring work is completed in alignment with GMP requirements, safety standards, and facility specifications.
- Support the installation, repair, commissioning, and qualification of equipment, utilities, and processes.
- Oversee calibration, preventive maintenance, and GMP equipment monitoring programs, ensuring documentation meets current regulatory and industry standards.
- Develop and optimize CMMS workflows to accurately document preventive and corrective maintenance activities.
- Oversee EHS programs, including inspections and interactions with city and regulatory agencies, ensuring compliance with hazardous materials and waste regulations.
- Manage pest control program.
- Provide oversight for building security, janitorial services, internal logistics, and onsite events.
- Conduct routine facility walkthroughs across manufacturing, quality, and technical areas to ensure compliance and readiness.
- Maintain and manage compliance documentation; lead investigations and author/review SOPs, work instructions, deviations, CAPAs, and change management records.
- Contribute to the development and review of facility policies and procedures.
- Plan and execute change controls related to qualification and facility projects.
- Manage vendor relationships, including bid solicitation, vendor evaluations, and creation of work orders and purchase orders.
- Serve as the primary facilities liaison with property management, coordinating building services, lease‑related obligations, and resolution of site‑level issues.
- Manages operational expenses for maintenance and services; tracks costs. Supports site OPEX; drafts CAPEX proposals; contributes to multi-year lifecycle planning.
Requirements
Basic Qualifications
- Master’s degree with 6+ years of facilities maintenance experience in medical device/pharma, OR
- Bachelor’s degree with 8+ years of experience in medical device /pharma facilities maintenance, OR
- High School diploma with 12+ years of experience in medical device /pharma facilities maintenance.
Preferred Qualifications
- 10+ years of relevant experience and/or a BS/BA in a related field.
- Strong background in regulated implantable medical device or pharmaceutical environments.
- Exceptional organizational skills with the ability to plan, coordinate, and track multiple operational projects with a high level of detail.
- Demonstrated hands‑on proficiency with GMP utilities and equipment, including mechanical and electrical systems, with strong troubleshooting, repair, and on‑the‑floor technical support capabilities.
- Experience working in cleanroom environments with knowledge of contamination‑control best practices.
- Proven supervisory experience in a highly regulated manufacturing setting, with the ability to build and lead high‑performing teams.
- Excellent written and verbal communication skills, along with strong interpersonal abilities.
- Demonstrated ability to manage multiple priorities and meet time‑sensitive deadlines.
Pay Range: $155,000 - $185,000
Benefits
- Medical
- Dental and Vision
- Flexible Spending Account (FSA)
- 401K with Company Safe Harbor Match: 100% /up to 4%
- Life Insurance
- Long Term Disability
- Home Office Stipend
- Commuter benefits