GMP Facilities Manager – Instrumentation

Just-Evotec Biologics is seeking a highly-motivated and driven Facilities Manager – Instrumentation that desires a significant opportunity to improve worldwide access to biotherapeutics.  This position will provide technical support the manufacturing facilities by ensuring manufacturing equipment, plant utilities and facilities are operating within specifications to meet the requirements for biopharmaceutical manufacturing.

Responsibilities:

• Responsible for the day-to-day coordination of calibration activities, testing, and troubleshooting process control instrumentation in compliance ISO (9001 & 17025), ANSI/NCSL Z540 and with our standards operating procedures
• Coordinate and interact effectively with System Owners, vendors, and technical teams in the development of calibration procedures and with the definition of instrument and process tolerances
• Investigate equipment and instruments failures and lead the RCA in support of investigations
• Lead the implementation of CAPA’s and Change Control Program for GMP systems
• 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 calibration activities for utilities, process equipment, and lab equipment.
• Oversee installation, operation, maintenance, and repairs to ensure that equipment and instrumentation are installed and functioning according to specifications
• Ensure the completion of the preventative maintenance schedule and corrective maintenance backlog.
• Support the planning and scheduling of facility shutdowns and projects to meet organizational objectives.
• Manage calibration activities and the work order backlog in the CMMS system to ensure that all system data is updated, accurate, and compliant following approved procedures
• Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures, and purchases

Qualifications and Education Requirements:

• Bachelor’s degree in Electrical, Instrumentation or Control Engineering or related qualification
• 5+ years of experience calibration theory and practice, with mechanical calibration system on pharmaceutical manufacturing

Preferred Qualifications:

• Experience understanding of instrumentation of bioreactors, chromatography, viral filtration, and other Biopharmaceutical process equipment
• Working knowledge of electrical and mechanical systems
• Working knowledge of procurement and contracts
• Knowledge of health, safety and environmental regulations

• 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