GMP Equipment Monitoring Technician, 3rd Shift - Columbus, Ohio

Forge Your Future with Us:  · At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physician ...

Job description

Forge Your Future with Us: 

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. 

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen — you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. 

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together. 

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. 

If you're ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. 

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. 

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. 

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. 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.  

Work Environment and Physical Demands   

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs. 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  

We've Got You Covered:  

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:  

Health from day one 

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.  

Time to recharge 

• 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.  

Rewarding your impact 

• 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.  

Your wellness, supported 

• 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.  

Fuel for your workday 

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what's next.  

Grow with us 

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.