Sr. Calibration & Controls Technician

About Forge  

Our mission at Forge Biologics, 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 Sr. Calibration and Controls Technician is responsible for the overall calibration and controls maintenance, and the continuous improvement of GMP manufacturing, laboratory and utility equipment and control systems in accordance with the OEM recommendations and internal SOP’s. This role is responsible for monitoring the equipment and systems tied to the Building Management/Controls and Monitoring systems.

What You’ll Do: 

• Assess instrumentation and control systems as part of the equipment onboarding process.  Provide guidance on appropriate instrumentation and control systems to be implemented as part of the site standardization strategy.  Identifies new calibration standards as required. 
• Participate in project reviews from engineering conceptualization through detailed design and start-up for the selection of instrumentation and controls 
• Performs planned calibrations and corrective work on instrumentation in accordance with internal procedures 
• Manages contractor services on externally performed calibrations, including obtaining quotes and contracts, scheduling, on-site escorting, supervision, and providing training that ensures all applicable documentation is in accordance with internal procedures 
• Troubleshoot, maintain, and repair control systems, such as PLCs (Programmable Logic Controllers), SCADA (Supervisory Control and Data Acquisition) systems, and DCS (Distributed Control Systems) 
• Interfaces with various departments to complete calibrations, while minimizing equipment downtime - including Manufacturing, Quality Control, Process Development, Facilities and other departments as applicable 
• Communicates as found instrument OOT (Out of Tolerance) to the department equipment owners and reports OOT to the Calibration and Controls Lead.  Initiate deviations for OOT events in the Quality Management System. Acts as SME in investigations as required 
• Supports periodic review of instrument OOTs and proposes areas for improvement or correction 
• Write, edit and review calibration procedures 
• Develops and maintains troubleshooting narratives for control systems 
• Actively monitors and pulls trends for critical systems tied to the Building Management Control System (Metasys).  Responds to alarms from the BMS. Reports findings to associated equipment owners. 
• Calibrate various types of instruments and equipment, such as temperature, pressure, flow, and level transmitters 
• Actively monitors and pulls trends from the Building Monitoring System (OceaSoft).  Reports trends and other information to the associated equipment owners 
• Actively monitors the Building Automation System and troubleshoots automation controls issues
• Uploads completed calibration documentation and other corrective work into the Maintenance CMMS system (Blue Mountain Regulatory Asset Manager (BMRAM)), while adhering to Good Documentation Practices 

What You’ll Bring: 

• 5+ years of experience installing, maintaining, testing, repairing, and calibrating a wide range of complex equipment within a cGMP environment, or other highly regulated environment 
• Bachelor's degree in engineering, electronics, or a related field is preferred 
• Effective communication skills reporting calibration and controls issues as it relates to product quality  
• Ability to troubleshoot problems within complex instrumentation and control systems, identify root causes and propose and implement solutions 
• Experience with the selection of calibration standards and calibration software programs 
• Experience with CMMS related systems and management of documentation 
• Troubleshooting and support after hours as required (response to building management and building moni