Associate Manager, GMP Maintenance

Forge Biologics•Columbus, OH

6d•Onsite

About The Position

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.

Requirements

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 corrective maintenance of complex laboratory and manufacturing equipment.
Ability to troubleshoot and resolve complex mechanical and instrument issues while ensuring minimal operational impact.
Strong organizational and time management skills with the ability to manage multiple priorities, work orders, and competing deadlines in a fast-paced environment.
Strong communication skills, particularly in reporting facility issues and coordinating cross-functional maintenance efforts.
Willingness to support after-hours troubleshooting and participate in an on-call rotation.
Ability to work in a cleanroom environment while wearing appropriate gowning and PPE.

Nice To Haves

Familiarity with documentation practices in regulated industries (GMP, ISO, FDA).
Previous leadership experience.
Experience with CMMS related systems (e.g. BMRAM) for documentation and maintenance tracking.

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.
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.
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.
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.