GMP Equipment Monitoring Technician, 3rd Shift

Forge Biologics•Columbus, OH

3h•Onsite

About The Position

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.

Requirements

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 independently and collaboratively across cross-functional teams, including Process Development, Quality, Facilities & Engineering.
Strong organizational and time-management skills to prioritize tasks and meet operational deadlines.
Ability to work in loud noise environments, and in cleanroom environments, while wearing appropriate gowning and Personal Protective Equipment (PPE).
Ability to work flexible 3rd shift hours, including weekends and holidays, in support of GMP production schedules.
High School diploma required.

Responsibilities

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.

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.