Associate Manager, GMP Maintenance

About Forge  

Our mission at Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is to enable access to life changing gene therapies and help 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 Associate Manager of GMP Mechanical Maintenance is responsible for the overall preventative, predictive and corrective maintenance strategies of GMP manufacturing, laboratory, and utility equipment in accordance with the OEM recommendations, best practices and internal SOPs.  The Associate Manager, GMP Mechanical Maintenance utilizes the latest tools and technologies to drive equipment and system uptime, performance and overall reliability.

What You’ll Do: 

• Design and implementation of robust preventive maintenance strategies for critical site assets.
• Implements strategies from the Asset Responsible Care Program.
• Trains staff on latest maintenance techniques and best practices.
• Provides mechanical maintenance expertise and asset maintainability expertise during project reviews from engineering conceptualization through detailed design and start-up.
• Supports new equipment installations and Site Acceptance Testing (SAT).
• Leads planned and corrective work on GMP and non-GMP mechanical equipment in accordance with internal procedures meeting all Quality and EHSS requirements.
• Implements a structure for daily rounds which focuses on and documents utility equipment performance.
• Evaluates and implements best practices for in-house vs external maintenance work.
• As applicable, manages contractor services on externally performed equipment preventative and corrective maintenance. Assesses all provided documentation for cGMP and GDP principles.
• Interfaces with various departments to complete equipment maintenance and repairs including Manufacturing, Quality Control, Process Development, Facilities and other departments while minimizing downtime. Works with departments on hand-over of equipment after maintenance and ensures its performance during re-start.
• Develops JSAs for associated work.
• Supports implementation and continued maintenance of the LOTO program.
• Supports periodic review of equipment performance and identifies areas for continuous improvement
• Leads/supports equipment deviation investigations as required.
• Write, edit and review maintenance procedures including WI (Work Instructions) and WPTs (Work Plan Templates). Develops standardized approach to WPTs.
• Maintains knowledge and troubleshooting proficiency for process equipment systems. Troubleshoot utility systems including RO, HVAC, Steam Generation, Chilled Water, Hot Water and Compressed Air.
• Develops and maintains troubleshooting narratives for equipment systems.
• Actively monitors and pulls trends for critical systems tied to the Building Management Control System (Metasys). Responds to alarms from the Building Control System. Reports findings to associated equipment owners.
• Actively monitors and pulls trends from the Building Monitoring System (OceaSoft). Reports trends and other information to the associated equipment owners.
• Part of the monthly planned work order review process and end of month reconciliation of work completed.
• Uploads completed mechanical preventative maintenance documentation and other corrective maintenance work into the Maintenance CMMS system (Blue Mountain Regulatory Asset Manager (BMRAM)) while adhering to Good Documentation Practices.
• Plays a critical role in the development and maintenance of the spare parts program.
• Support Factory Acceptance Testing (FAT).
• Partner with the Manager Plant & Reliability Engineering to identify areas for continuous improvement.
• Troubleshooting and support after hours as required or on-call (response to building management and building monitoring systems).

What You’ll Bring: 

• 8+ years of experience mai