Facility 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.   

Summary: 

The Facility Maintenance Technician is responsible for the overall preventative, predictive and corrective maintenance strategies of GMP manufacturing, laboratory and utility equipment in accordance with the OEM recommendations and internal SOPs.  The Facility Maintenance Technician has responsibility for the monitoring and response to equipment and systems tied to the Building Management/Controls and Monitoring systems.

What You'll Do:

• Assist in the planning and execution of equipment installations, upgrades, and modifications, ensuring alignment with site standardization strategies.
• Participate in project reviews from engineering conceptualization through detailed design and start-up for the selection of equipment.
• Conduct planned and corrective maintenance on GMP and non-GMP mechanical equipment, adhering to Quality and EHSS standards.
• Perform daily rounds and document utility equipment performance.
• Manage contractor services for equipment maintenance, including scheduling, supervision, and ensuring documentation compliance.
• Collaborate with various departments, including Manufacturing, Quality Control, Process Development, Facilities, to minimize downtime during maintenance and repairs, ensuring smooth handover and equipment performance during re-start.
• Develop Job Safety Analyses (JSAs) and continuously review equipment performance, identifying and proposing areas for continuous improvement.
• Communicate maintenance findings to equipment owners and act as a subject matter expert (SME) during investigations.
• Write, edit, and review maintenance procedures, including Work Instructions (WIs) and Work Plan Templates (WPTs).
• Perform Site Acceptance Testing (SAT).
• Maintain and troubleshoot process equipment systems, including WFI, RO, HVAC, Steam Generation, Chilled Water, Hot Water, and Compressed Air systems.
• Monitor critical systems via Building Management Control System (Metasys) and Building Monitoring System (OceaSoft), responding to alarms and reporting trends to equipment owners.
• Document maintenance activities in the CMMS (Blue Mountain Regulatory Asset Manager) following Good Documentation Practices.
• Support the spare parts program by identifying critical spare parts for equipment.
• Assist in Factory Acceptance Testing (FAT) and collaborate with departmental engineers (Plant, Process and Project), Calibration, and Controls Technicians.
• Perform gas cylinder change-outs for GMP Manufacturing and Laboratory / Development areas.
• Provide troubleshooting support, including after-hours or on-call response as needed.
• Assist with general site services, facility repairs, and grounds maintenance as required.

What You'll Bring:

• Previous experience as a Maintenance Technician in a manufacturing environment, preferably within a regulated industry.
• 5+ years of experience with complex mechanical systems and equipment.
• 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 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