GMP Equipment Monitoring Technician, 3rd Shift

About Forge

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping 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 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.

What You'll Do

• 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.

What You'll Bring

• High School diploma or 1 year experience in a relevant field
• Ability to work flexible hours, including off-shift times between 6pm and 6am, based on GMP production run schedules
• Previous experience in equipment monitoring in a GMP, QC, or other regulated environments
• Proficiency in troubleshooting and repairing complex equipment
• Strong organizational and time-management abilities
• Excellent communication and collaboration skills
• Familiarity with regulatory requirements for data management in a manufacturing environment specific for equipment (BMRAM) is a plus
• Understanding of manufacturing processes in the biotech industry is a plus

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.

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.

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.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by. 

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches