Sr GMP Facilities Manager - Compliance

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Job description

Just-Evotec Biologics is seeking a highly-motivated and driven Facilities Manager - Compliance 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 compliant operation and maintenance of utilities and facilities to meet the needs of the company.

Responsibilities:

• This position has overall responsibility for the operation and surveillance program for the critical GMP production areas and critical GMP utilities, including the Water-For-Injection (WFI), Pure Steam, GMP Process Gases and the Environmental Control Program
• Develop and implement a facility management program including preventative maintenance, spare parts inventory, and life-cycle requirements
• Lead the investigation of facility and equipment alarms and system failures and responsible for the implementation of Corrective Actions/Preventive Actions (CAPA's) and change controls for GMP systems
• Provide oversight of the Maintenance Work Order and Calibration Programs and ensure compliance with the timely execution of the scheduled activities
• Conduct and document regular inspections, maintenance and calibration of facilities and equipment
• Establish and Monitor Key Performance Indicators and participates in daily work center meetings
• Coordinate and document metrology activities for utilities, process equipment, and lab equipment.
• Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation
• Provide prompt response to requests and issues from Manufacturing and Quality
• 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

Preferred Qualifications:

• Experience with change control and validation related to GMP utilities and equipment
• Practical knowledge of eQMS, automation (DeltaV), CMMS and BAS systems
• Working knowledge of utilities and mechanical systems
• Working knowledge of procurement and contracts
• Knowledge of health, safety and environmental regulations
• Experience in 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 250+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area.

Middle Management