Calibration and Controls Technician III/Sr.

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.  Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality.  Forge has a 200,000 ft² facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters.  The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.  By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

Summary: 

The Calibration and Controls Technician is responsible for the overall calibration and controls maintenance and continuous improvement of GMP manufacturing, laboratory and utility equipment and control systems in accordance with the OEM recommendations and internal SOPs.  The Calibration and Controls Technician has responsibility for monitoring of equipment and systems tied to the Building Management/Controls and Monitoring systems.

Responsibilities:

• 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
• Perform initial new equipment calibrations as required
• 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
• 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
• Maintains knowledge and troubleshooting proficiency for installed control systems
• 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.
• Actively monitors and pulls trends from the Building Monitoring System (OceaSoft). Reports trends and other information to the associated equipment owners
• 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
• Supports the spare parts program by identifying critical spare instrumentation and controls components
• Troubleshooting and support after hours as required (response to building management and building monitoring systems)

Qualifications:

• 8+ years of related experience in calibration and controls
• Extensive experience installing, maintaining, testing, repairing, and calibrating a wide range of complex equipment within a cGMP environment, or other highly regulated environment preferred
• Effective communication skills reporting calibration and controls issues as it relates to product quality. Effective troubleshooting resolution and communication skills
• 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
• Proficiency in MS Office Suite preferred
• Must be a self-starter, detail oriented, able to perform complex tasks and work cross functionally with other departments with minimal supervision
• Preferred: Experience in documentation management within a structured Quality System (ISO, FDA)
• In our commitment to safety of our employees and customers a COVID vaccination is required 

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