About Us
With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, we are truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.
Key Responsibilities:
The Facilities Manager is responsible for directing a professional team of individuals in the day-to-day upkeep and maintenance of the buildings and grounds for GBI Biomanufacturing. The Facilities Manager will schedule and execute through his team and appropriate contract services all routine maintenance activities on GMP support equipment and systems. The team consists of Process Mechanics, Facilities Technicians and Facilities Specialists. The Facilities Manager needs to understand HVAC systems, compressed gas systems, boilers, refrigeration systems and have a background in remote environmental monitoring systems and building management systems. The Facilities Manager will work within a regulated environment and need to understand quality systems and good documentation practices. The role requires the Facilities Manager to be able to develop, revise, and direct preventative maintenance Standard Operating Procedures (SOP), and company policies to ensure prompt completion of important tasks to support company goals and clients’ projects.
- Collaborates with cross-functional teams and systems.
- Supports and writes investigations and assist in development and implementation of CAPAs.
- Assists in the execution of the scheduled preventative maintenance and documentation of Work Orders.
- Oversees and directs maintenance personnel with repairs.
- Hold direct report team accountable for performance.
- Conduct annual performance review of direct reports.
- Support and develops responses for internal and external audits.
- Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, and operation of equipment, facility, and utilities.
- Oversight of REES Environmental Monitoring System.
- Oversight of MasterControl PM and CAL module ensuring completion per schedule.
- Support the purchase and implementation of new equipment and spare parts.
- Identify the equipment, systems and processes that do not operate efficiently. Develop and implement corrective actions to improve efficiency
- Ensure that required parts are available for the projects, preventative maintenance, and repairs ahead of schedule.
- Coordinates activities of contractors to ensure projects, maintenance and PM(s) are completed on time with supporting documentation.
- Maintain HEPA recertification schedule with contractors ensuring cleanrooms and BSC/LFH remain in a state of compliance.
- Plan and schedule the Boiler, Fire Extinguishers and Waste Management Annual PM and inspections.
- Responsible for equipment upgrades and completing necessary equipment change control documentation.
- Responsible for daily data logging/reviewing of the Environmental Monitoring System for Temperature and RH conditions.
- Ensure the building and grounds are cleaned on an ongoing schedule including break room and rest rooms.
The ideal candidate will have:
- Must have demonstrated knowledge of electrical and mechanical systems in a regulated environment.
- Trade school degree or certification in HVAC, Boilermaker, Electrician or similar with minimal 10 years experience in a regulated facility.
- Bachelor’s degree in Engineering: Mechanical, Industrial, or Electrical with minimal 5 years related experience in a regulated facility.
- Related pharmaceutical, biotech or medical devices preferred.
- Facility /Industrial maintenance experience required.
- Technical Writing skills.
- Ability to manage multiple priorities and advance several tasks in parallel.
- Experience supervising mechanical staff is required.
