Associate Manager, GMP Maintenance

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.

If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.

About The Role:

The Associate Manager of GMP Maintenance leads a team of Maintenance Technicians responsible for completing assigned planned and corrective maintenance work orders on GMP manufacturing and laboratory equipment. This role oversees GMP maintenance and continuous improvement of manufacturing, laboratory, and associated equipment control systems in accordance with OEM recommendations and internal SOPs.

Responsibilities:

• Assess and monitor the condition of GMP equipment, identifying opportunities for improvement, and ensuring regulatory compliance.
• Collaborate with the CMMS team to develop, enhance, and implement robust preventive maintenance plans and schedules for critical systems.
• Execute planned and corrective maintenance activities on GMP and non-GMP assets in accordance with Quality and EHSS standards.
• Accurately account for spare parts and consumables used in maintenance processes, supporting stocking, reordering, and identification of critical spare parts to ensure infrastructure reliability.
• Provide data insights to support capital investment initiatives aimed at improving equipment reliability.

Vendor & Contractor Oversight

• Oversee external contractors performing preventative and corrective maintenance, including supervision, and documentation review.
• Review third-party maintenance scopes to ensure proper documentation and alignment with internal procedures.

Cross-Functional Collaboration and Support

• Collaborate cross-functionally with Scheduling & Planning, GMP Manufacturing, Supply Chain QC, QA, Quality Engineering, and non-GMP Lab Owners to coordinate maintenance activities and minimize downtime.
• Support equipment handovers and restart verifications following maintenance or repairs.
• Perform calibrations under the direction of Metrology.

Documentation & Compliance

• Maintain accurate maintenance records within the CMMS (Blue Mountain RAM), ensuring adherence to Good Documentation Practices.
• Assist in the development and maintenance of Job Safety Analyses (JSAs), Work Instructions (WIs), and Work Plan Templates (WPTs).
• Uploads completed maintenance documentation and other corrective work summaries into the Maintenance CMMS system (Blue Mountain Regulatory Asset Manager (BMRAM)), while adhering to Good Documentation Practices.

Qualifications:

• 7+ years of experience in maintenance and/or instrument calibration within a regulated environment.
• Bachelor's degree in a related technical field, or equivalent professional experience.
• Demonstrated experience with preventive and…