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 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.
Preferred Skills:- 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.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands The work environment for this position includes manufacturing, utility, and maintenance areas within a regulated facility, as well as occasional outdoor work. Employees may be exposed to mechanical equipment, moving machinery, varying temperatures, and moderate noise levels. Work may be performed in confined spaces, elevated locations, or areas requiring strict adherence to safety and cleanliness standards.
This role requires the physical capability to perform routine maintenance tasks, including standing, walking, bending, stooping, reaching, and working in tight or awkward spaces for extended periods. The position may require lifting, pushing, or pulling materials and equipment weighing up to 50 pounds.
Additional physical and environmental requirements include:
- Ability to gown and work in Classified Areas of the facility, including ISO 7 and ISO 8 environments, following sterile gowning procedures
- Ability to move safely over uneven terrain and navigate confined or restricted spaces
- Ability to safely climb ladders and work at heights while carrying up to 50 pounds
- Ability to properly wear and use required personal protective equipment (PPE), including safety footwear, eye protection, gloves, and other protective gear as necessary.
We've Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
