GMP Facilites Manager
Just-Evotec Biologics is seeking a highly-motivated and driven GMP Facilities Manager that desires a significant opportunity to improve worldwide access to biotherapeutics. This position will be responsible for the effective functioning of a cGMP manufacturing facility and providing an efficient and safe working environment using best practices to manage resources, services and processes to meet the needs of the company.
- Responsible for the day-to-day operation and maintenance of the equipment and utilities supporting a cGMP biologic manufacturing operation. This position has overall responsibility for the process equipment, Water-For-Injection (WFI) system, chillers, boilers, water treatment, air handling, autoclaves, clean compressed air and process gases, and other support areas.
- Develop and implement a facility management program including preventative maintenance, spare parts inventory, and life-cycle requirements
- Respond to and document facility and equipment alarms and system failures
- Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures and manufacturing documentation.
- Conduct and document regular inspections, maintenance and calibration of facilities and equipment
- Coordinate and document metrology activities for utilities, process equipment, and lab equipment.
- Provide prompt response to requests and issues from Manufacturing and Quality
- Plan and manage facility services such as janitorial, GMP gowning supply, and waste disposal
- Provide support for ergonomics, business continuity and EH&S functions
- Manage and review service contracts to ensure facility management needs are being met
- Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures and purchases
Qualifications and Education Requirements:
- Bachelor's degree in Facilities Management, Facilities Engineering or related qualification
- 5+ years of experience in a GMP environment with demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a biologic manufacturing environment, including process, equipment and facility validation experience
- Experience with change control and validation related to GMP utilities and equipment
- Practical knowledge of eQMS, automation (DeltaV), and BAS systems
- Working knowledge of electrical and mechanical systems
- Working knowledge of procurement and contracts
- Knowledge of health, safety and environmental regulations
- Experience in construction, maintenance and all facets of facility operation
- Excellent verbal and written communication skills
- Possess planning, organizational, problem-solving and negotiation skills
- Strong focus on quality and attention to detail
- Motivated, self-starter with customer service and team orientation
About Just - Evotec Biologics
Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers