Plant & Reliability Engineer

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 Plant & Reliability Engineer is responsible for the support of overall facility and equipment performance, reliability, and compliance for GMP and non-GMP production/operations.  The Plant & Reliability Engineer performs troubleshooting and monitoring of key GMP assets with the expectation of driving quality and safety compliance, asset availability and overall asset health. This role provides engineering technical expertise support between the asset owner (i.e. Production, Development), Quality Assurance and Maintenance/ Facilities and EHSS to support the overall strategy of Asset Responsible Care.  This position focuses predominantly on GMP assets but also will be involved in monitoring non-GMP assets.

What You’ll Do: 

• Provide hands-on reliability support for GMP and non-GMP equipment and facilities.
• Day-to-day operational/manufacturing support for client campaigns and engineering runs
• Support asset/facility work prioritization
• Develop robust strategies in preventive and predictive maintenance
• Support equipment and facility compliance, including Deviations, CAPAs, Change Controls, and audit support
• Maintain Health Score Cards for critical equipment/assets and participate in PHAs (Process Hazard Analyses), PSSRs (Pre-startup Safety Reviews), and equipment/facility FMEAs (Failure Modes and Effects Analyses)
• Develop, review, and revise equipment operational SOPs and GMP training programs
• Support Preventive Maintenance (PM) optimization, work instructions & work plan improvements and overall PM strategy
• Support shutdown management of activities (master schedules for shutdowns including planned, corrective and project-based activities)
• Implement improvement efforts to assets/facility that support compliance (quality and safety improvements)
• Support contractor management program and evaluate improvements with externally performed preventive maintenance (documentation and practices)
• Participates in the FAT/SAT process as required
• Collaborates with Project Engineering on the handoff of newly designed and installed systems, identifies equipment improvements, and provides CapEx requirements for planning.
• Lead/support small to medium size CapEx projects
• Provide guidance on asset standardization and reliability for new projects
• Monitor Building Automation System (BAS) and GMP Cleanroom environments to ensure compliance
• Provide after-hours troubleshooting support as needed

What You’ll Bring: 

• 4+ years of experience in plant engineering, reliability engineering, or a similar role within a regulated manufacturing environment (ISO, FDA, GMP)
• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or related field (preferred)
• Experience supporting reliability-centered maintenance (RCM) programs
• Strong understanding of manufacturing processes, equipment reliability principles and predictive maintenance technologies
• Ability to implement proactive maintenance strategies to minimize downtime and maximize equipment performance, utilizing failure analysis, FMEA, RCM, and reliability modeling techniques
• Experience with Quality Management Systems (i.e. Veeva, TrackWise), CMMS, process control, and environmental control and monitoring systems
• Able to clearly identify issues and provide robust technical solutions
• Ability to support the design of bioprocessing equipment
• Nice to have: Experience in engineering design and engineering troubleshooting in a regulated environment (ISO, FDA)
• Nice to have: CAD experience

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

Work Environment and Physical Demands 

This position works in both a warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level in the work environment ranges from moderate to occasionally loud. Must be able to lift, carry, push, and/or pull objects weighing up to 35 lbs. Ability to frequently operate a computer, and communicate with others in person, over the phone, and via other devices. Must be able to move about the facility for moderate to extended periods of time. Ability to wear task dependent personal protective equipment as needed.  

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 
• Competitive paid time off plan 
• 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) 
• Onsite fitness facility  
• Professional & Personal development resources