Sr. GMP Maintenance Technician

Forge Biologics•Columbus, OH

3d•Onsite

About The Position

The Sr. GMP Maintenance Technician develops and executes preventative and corrective maintenance strategies for GMP manufacturing and laboratory equipment, following OEM recommendations and internal SOPs. The role monitors and responds to equipment and systems connected to Building Management, Controls, and Monitoring systems, and supports continuous improvement of maintenance documentation, including SOPs, Work Instructions (WIs), Work Plan Templates (WPTs), and Maintenance Decision Trees (MDTs). The position works with equipment and mechanical systems across the site, supports equipment onboarding and project reviews, performs maintenance and installations, and coordinates contractor services. It also contributes to safety and quality compliance, equipment troubleshooting and performance improvements, maintenance documentation, and shutdown activities. The role may provide after-hours troubleshooting support and participate in an on-call rotation as needed. The position is based at Forge Biologics’ The Hearth facility in Columbus, Ohio. Work may involve gowning into ISO 7 and 8 classified areas, handling materials or equipment, traversing uneven terrain or confined spaces, climbing ladders while carrying weight, and wearing required personal protective equipment.

Requirements

At least 5 years of experience working with complex mechanical systems, preferably in a GMP or other highly regulated environment.
Experience and aptitude with complex equipment.
Experience with selection of mechanical equipment.
Experience with CMMS-related systems and documentation management.
Effective communication skills for reporting mechanical issues as they relate to product quality, and effective troubleshooting resolution and communication.
High school diploma or GED.
Willingness to support after-hours troubleshooting and participate in an on-call rotation as needed.

Nice To Haves

Experience with the design and selection of bioprocessing equipment.
Experience with CMMS and environmental control and monitoring systems.
General understanding of process control and computerized systems.
Experience in engineering design and engineering troubleshooting in a regulated environment, such as ISO or FDA-regulated work.

Responsibilities

Assess equipment and mechanical systems and provide guidance during onboarding for site standardization.
Participate in project reviews from concept through start-up, with a focus on equipment selection.
Coordinate and prioritize maintenance compliance with Quality standards.
Perform or assist with new equipment installations and Site Acceptance Testing (SAT).
Execute planned and corrective maintenance on GMP and non-GMP equipment in accordance with Quality and EHSS standards.
Conduct periodic GMP and safety walk-downs to identify areas for improvement.
Lead and support contractor services for external equipment maintenance, including obtaining quotes, scheduling, and on-site supervision.
Collaborate with departments to ensure timely equipment maintenance, minimize downtime, and enable smooth handovers.
Support development of Job Safety Analyses (JSAs).
Review equipment performance periodically and identify and propose improvements.
Report preventive maintenance findings and equipment performance deviations, and serve as a subject matter expert during investigations.
Provide feedback on maintenance procedures and update Work Instructions (WIs) and Work Plan Templates (WPTs).
Maintain troubleshooting proficiency for process and utility systems and assist with troubleshooting as needed.
Respond to alarms and monitor trends from Building Control and Monitoring Systems.
Upload maintenance documentation into the CMMS system in accordance with Good Documentation Practices.
Identify critical spare parts for equipment.
Support other departmental engineers and technicians as needed.
Perform gas cylinder change-outs and general site services, including repairs and maintenance.
Manage shutdown activities and provide after-hours troubleshooting support as needed.

Benefits

Health, dental, and vision insurance beginning on the first day, with 90% of premiums covered for the employee and family.
Competitive paid time off plan.
12 weeks of fully paid parental leave.
Annual bonus opportunities for full-time team members.
401(k) with company match.
Employee discounts, including childcare and dependent care savings.
Onsite fitness facility.
Mental health counseling and financial planning services through the Employee Assistance Program.
Employer-paid short- and long-term disability coverage.
Fully stocked kitchen with free snacks and beverages.
Professional development resources, training, and mentorship programs.