Plant & Reliability Engineer

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help 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:

We are seeking a highly motivated and skilled Plant & Reliability Engineer to join our Facilities & Engineering team. 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, 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:

• Hands on facility & equipment reliability support for GMP and non-GMP assets
• Develops robust strategies in preventive and predictive maintenance
• Supports equipment and facility Deviations, CAPAs and Change Controls
• Develop and implement reliability-centered maintenance (RCM) programs to optimize the performance of manufacturing equipment and facilities
• Maintains Health Score Cards for critical equipment/assets. Provides Health Score Card overview to equipment owners, Quality and other management as needed
• Participates in PHAs and PSSRs (Pre-startup Safety Reviews)
• Audit support as required for equipment and facilities
• Conduct equipment reliability assessments, failure mode and effects analysis (FMEA), and root cause analysis (RCA) to identify and mitigate potential failure modes.
• Assist in the development, revision and review of equipment operational SOPs
• Supports Preventive Maintenance optimization and overall strategy
• Develop site GMP trainings specific to equipment operation
• Support shutdown management of activities (master schedules for shutdowns including: planned, corrective and project-based activities)
• Implements changes to existing equipment/assets that support compliance (quality and safety improvements)
• Evaluates areas for improvement with externally performed preventive maintenance (documentation and practices)
• Participates in the FAT/SAT process as required
• Evaluates maintenance procedures, work instructions and work plan templates related to plant engineering and reliability activities
• Works closely with Project Engineering on the hand-off of newly designed and installed systems and facilities
• Identifies improvements to equipment and provides the CapEx requirements to Project Engineering for CapEx planning
• Support new projects by providing guidance on asset standardization and overall asset reliability expectations
• Building Automation System (BAS) monitoring and GMP Cleanroom environment monitoring

What You'll Bring:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or related field
• Strong understanding of manufacturing processes & equipment reliability principles
• Experience implementing reliability-centered maintenance (RCM) programs and predictive maintenance technologies
• Proven experience in plant engineering, reliability engineering, or similar role within a regulated manufacturing environment
• Demonstrated ability to implement proactive maintenance strategies to minimize downtime and maximize equipment performance
• Strong knowledge of reliability engineering principles, including failure analysis, FMEA, RCM, and reliability modeling techniques
• Excellent communication, problem-solving skills and the ability to work effectively in cross-functional teams
• Ability to clearly identify issues and provide robust technical solutions
• Experience with computerized maintenance management system (CMMS), environmental control and monitoring systems
• After hours troubleshooting support as needed
• Familiarity with regulatory requirements and quality standards applicable to regulated environments (cGMP, FDA, ISO) is preferred
• Preferred: Experience in engineering design and engineering troubleshooting in a regulated environment (ISO, FDA

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
• 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