GMP Equipment Monitoring Technician, 3rd Shift

About Forge  

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.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.    

About The Role  

The 3rd Shift GMP Equipment Monitoring Technician will oversee, gather, and consolidate manufacturing data from various sources, including production equipment, quality control systems, and laboratory instruments. This role will focus on generating regular reports on equipment performance, maintenance activities, and any issues encountered.

The GMP Equipment Monitoring Technician’s responsibilities will evolve as the organization grows. This position is responsible for collaborating with cross-functional teams (Process Development, Quality, Facilities & Engineering) to identify opportunities for improving equipment performance and maintenance processes and implement best practices and innovative solutions. In this role, the individual will ensure equipment is operated and maintained in a manner that promotes a safe working environment. The ideal candidate understands the importance of reliability, support, maintenance, and collaboration within a regulated manufacturing environment.

What You’ll Do  

• Continuously monitor GMP (Good Manufacturing Practice) and QC (Quality Control) equipment to ensure proper functionality.
• Perform regular maintenance and calibration of equipment to maintain accuracy and compliance with regulatory standards.
• Accurately record equipment performance data and maintenance activities in logbooks.
• Maintain detailed records and documentation for audit and compliance purposes.
• Diagnose and troubleshoot equipment issues promptly to minimize downtime.
• Conduct or coordinate necessary repairs and replacements of faulty components in collaboration with F&E through Blue Mountain Regulatory Assets Management software.
• Ensure all equipment monitoring and maintenance activities comply with GMP, QC, and regulatory requirements.
• Update regulatory changes and implement necessary adjustments to equipment monitoring protocols.
• Document calibration and validation processes and outcomes as per regulatory standards.
• Monitor environmental conditions (e.g., temperature, humidity) in manufacturing and QC areas.
• Assist QC teams with equipment setup and operation for testing and analysis.
• Ensure GMP/QC equipment is properly maintained and ready for use.
• Develop and execute preventive maintenance schedules for GMP and QC equipment.
• Proactively identify potential issues and address them before they impact operations.
• Maintain inventory of spare parts and consumables required for equipment maintenance and repairs.
• Ensure timely reordering of supplies to avoid interruptions in operations.

What You’ll Bring  

• Experience troubleshooting equipment within a manufacturing, laboratory, or other regulated environment.
• Ability to diagnose, troubleshoot, and resolve equipment issues in a timely manner.
• Excellent analytical and problem-solving skills to diagnose and resolve equipment performance issues efficiently.
• Strong documentation skills with attention to detail for maintaining logbooks, audit records, and compliance documentation.
• Ability to work flexible hours, including off-shift times between 10pm and 6am, based on GMP production run schedules.
• Ability to work independently and collaboratively across cross-functional teams, including Process Development, Quality, Facilities & Engineering.