GMP Maintenance Technician

Company Overview:

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

About the Role: 

The GMP Maintenance Technician is responsible for the overall preventative, predictive and corrective maintenance strategies of GMP manufacturing and laboratory equipment in accordance with the OEM recommendations and internal SOPs.  The GMP Maintenance Technician has responsibility for the monitoring and response to equipment and systems tied to the Building Management/Controls and Monitoring systems. This role will also be responsible for supporting improvements in maintenance documentation including SOPs, WIs (Work Instructions), WPTs (Work Plan Template) and MDTs.

What You'll Do:

• Assess and provide guidance on equipment and mechanical systems during onboarding for site standardization.
• Participate in project reviews from concept to start-up, focusing 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 per Quality and EHSS standards.
• Conduct periodic GMP/Safety walk-downs to identify improvement areas.
• Lead and support contractor services for external equipment maintenance, including quotes, scheduling, and on-site supervision.
• Collaborate with various departments to ensure timely equipment maintenance, minimizing downtime and ensuring smooth handovers.
• Support the development of Job Safety Analysis (JSAs).
• Review equipment performance periodically to identify and propose improvements.
• Report preventive maintenance findings and any equipment performance deviations; 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; assist with troubleshooting as needed.
• Respond to alarms and monitor trends from the Building Control and Monitoring Systems.
• Upload maintenance documentation into the CMMS system, adhering to Good Documentation Practices.
• Identify critical spare parts for the 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 as needed.
• Provide after-hours troubleshooting support as required.

What You'll Bring:

• 4+ years of experience working with complex mechanical systems, preferably in a GMP environment or other highly regulated environments, or 2+ years of experience with an Associate's or Bachelor's degree in a related field.
• Must be a self-starter, detail oriented, able to perform complex tasks and work cross functionally with other departments with minimal supervision.
• Effective communication skills reporting mechanical issues as it relates to product quality. Effective troubleshooting resolution and communication.
• Experience and aptitude with complex equipment.
• Experience with the selection of mechanical equipment.
• Experience with CMMS related systems and management of documentation.
• Preferred: Experience in documentation management within a structured Quality System (ISO, FDA).

Physical Requirements:

• May be required to lift up to 50 pounds of materials or equipment.
• Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)
• The ability to move safely over uneven terrain or in confined spaces
• The ability to safely climb ladders while carrying 40 pounds
• The ability to wear personal protective gear correctly as required

This job description is not designed to cover or contain a comprehensi