Sr. GMP Maintenance Technician

Forge Biologics•Columbus, OH

2d•Onsite

About The Position

The Sr. GMP Maintenance Technician develops and executes preventative and corrective maintenance strategies for GMP manufacturing and laboratory equipment in accordance with 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 GMP and non-GMP equipment, mechanical and utility systems, contractors, and cross-functional teams to maintain equipment performance, compliance, and availability. The technician may support shutdowns, provide after-hours troubleshooting, and participate in an on-call rotation. The work is based at Forge Biologics’ cGMP facility in Columbus, Ohio, and may involve gowning into classified ISO 7 and 8 areas and performing physically demanding tasks.

Requirements

At least 5 years of experience working with complex mechanical systems, preferably in a GMP or other highly regulated environment.
Experience and aptitude working with complex equipment.
Experience selecting mechanical equipment.
Experience with CMMS-related systems and documentation management.
Effective communication skills for reporting mechanical issues as they relate to product quality.
Effective troubleshooting, resolution, and communication skills.
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 settings.

Responsibilities

Assess equipment and mechanical systems and provide guidance during onboarding to support site standardization.
Participate in project reviews from concept through start-up, with a focus on equipment selection.
Coordinate and prioritize maintenance compliance in accordance with Quality standards.
Perform or assist with new equipment installations and Site Acceptance Testing (SAT).
Perform 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 contractors performing external equipment maintenance, including obtaining quotes, scheduling work, and supervising on-site activities.
Collaborate with departments to ensure timely equipment maintenance, minimize downtime, and support smooth handovers.
Support development of Job Safety Analyses (JSAs).
Periodically review equipment performance 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 and Work Plan Templates.
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.
Stocked kitchen with free snacks and beverages.
Professional development resources, training, and mentorship programs.