Senior Process Engineer, MS&T

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 Senior Process Engineer is a senior technical leader within Manufacturing Science & Technology (MSAT), responsible for leading the implementation of complex biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role provides technical leadership for equipment and process introduction, technical transfer, engineering studies, and complex troubleshooting through commissioning and transition to manufacturing, ensuring systems are fit-for-purpose and ready for operation.  This is a highly collaborative role that works closely with cross-functional teams including Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure processes are scalable, robust, and aligned with global regulatory expectations.

 

What You'll Do:

• Serve as a technical lead for upstream and downstream process equipment, identifying and supporting introduction of new systems or engineering-based improvements to equipment and facility system. This may include developing the technical justification and business case, translation of process requirements into equipment and system specifications, and supporting startup, and transition to GMP operations.
• Lead the planning, execution, and documentation of engineering studies to evaluate equipment performance, optimize recipe parameters, and develop engineering controls to support operational readiness.
• Partner with clients and internal cross functional teams in technology transfer plans, gap analysis, mapping of process flows, and FMEAs to ensure smooth and efficient technology transfer of gene therapy processes into manufacturing.
• Identify and implement continuous process optimizations, automation, and new technology to drive operational efficiency, reduce costs, and enhance product consistency.
• Support product lifecycle management incorporating phase appropriate requirements and develop process control strategies in preparation for process qualification.
• Support the development of technical documents such as study plans, manufacturing batch records, and SOPs, protocols, and reports.
• For new equipment, may participate and/or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), and commissioning.
• May participate in external as well as internal audits of the manufacturing facilities and processes.
• Assist in root cause investigations related to equipment and process performance and define sustainable corrective actions.
• Mentor process engineer team members, supporting technical and professional development.
• Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
• Builds effective partnerships with internal stakeholders to drive the business towards achieving company objectives.
• Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with company policies and cultural values.
• Additional responsibilities not listed may be assigned as needed by management.

What You'll Bring:

• Bachelor’s degree in engineering or related technical discipline; Master's or PhD preferred
• 5-8+ years of experience of relevant GMP engineering or manufacturing experience in biopharmaceutical or gene therapy environments.
• Deep technical knowledge of GMP manufacturing equipment and unit operations (e.g., bioreactors, chromatography, TFF, centrifugation, aseptic processing)
• Demonstrated experience leading cross-functional technical initiatives and capital projects.
• Strong knowledge of regulatory requirements and validation processes.
• Excellent problem-solving, analytical, and strategic thinking skills.
• Effective communication and cross-functional collaboration abilities.

Preferred:

• Experience supporting late-stage clinical or commercial manufacturing
• Prior system ownership responsibility for GMP equipment or processes.
• Demonstrated mentorship or technical leadership within an engineering or MSAT organization.

Physical Requirements:

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) occasionally. Employees may need to wear clean room gowning or 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.

Work Environment:

The work environment is fast paced.  This position has the utmost responsibility for compliance with rules and regulations regarding a safe and collaborative work environment relative to actions and conduct.

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.