Sr. GMP Manager Facilities Compliance - site based, Redmond, WA

Job Title: Sr. GMP Manager Facilities Compliance

Shifts: Days, Monday to Friday. 8:00am till 5:00pm, 8 hours, some flexibility.

About Us: this is who we are

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?   #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge, …in our journey

We’re looking for a passionate and curious Sr. GMP Manager Facilities Compliance to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

As a Sr. GMP Manager Facilities Compliance at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

This position is 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.

What You’ll Do:

• This position has overall responsibility for the 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, implement and maintain the 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 support to 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

• Audit 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

Who You Are:

• Bachelor’s degree in Facilities Management, Facilities Engineering or related qualification

• 2+ 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.

• 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, and of procurement and contracts

• Knowledge of health, safety and environmental regulations

• Experience in maintenance and all facets of facility operation

• Possess planning, organizational, problem-solving and negotiation skills

• Strong focus on quality and attention to detail

Why Join Us:

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. On site role.

• Inclusive Culture