Associate 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 youre 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 wont just watch innovation happen youll be part of it. Whether youre scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, youll 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. Were 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 were proud to see team members grow with us.

If youre 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 Associate Process Engineer (Drug Product) is an entry level technical contributor within Manufacturing Science and Technology (MS&T), responsible for supporting implementation and sustainment of biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role supports equipment and process introduction, technical transfer activities, engineering studies, and troubleshooting under the guidance of senior engineering staff to ensure systems are fit- for-purpose and ready for operations. 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.

Responsibilities:

• Support execution engineering studies to evaluate equipment performance, optimize process parameters, and assist with engineering controls supporting operational readiness.
• Assist with authoring and revising technical documentation including engineering studies, SOPs, protocols, and technical reports.
• Support technology transfer activities including documentation support, process flow mapping, and participation in risk assessments.
• Support commissioning and qualification activities including equipment documentation (URS), factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and vendor IQ/OQ.
• Support equipment troubleshooting activities and vendor interactions under guidance of senior engineering staff.
• Provide technical support to Manufacturing for routine operations, new process implementation, and equipment readiness activities.
• Support investigations related to process or equipment performance and assist with implementation of corrective actions.
• Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
• Build collaborative working relationships with internal stakeholders to drive the business towards achieving company objectives.
• Exhibits professional behavior consistent with company policies and cultural values.
• Additional responsibilities not listed may be assigned as needed by management

Qualifications:

• Bachelors degree, in life sciences, engineering or related field and 1+ years of experience, Masters degree with 0-1+ years of experience
• Demonstrates foundational technical knowledge in at least one focus area related to drug substance and/or drug product manufacturing, process or utility equipment, or automated systems.
• Demonstrated basic ability to interpret and utilize technical documentation including engineering drawings, piping and instrumentation diagrams (P&IDs), SOPs, vendor documentation, and equipment manuals.
• Strong organization and communication skills
• Strong attention to detail and ability to maintain accurate GMP documentation
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.

Preferred Qualifications:

• Prior experience in biologics or gene therapy manufacturing.
• Familiarity with electronic documentation systems or data analysis tools.

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.

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.

Weve Got You Covered:

At Forge Biologics, we believe our people deserve to be taken care of in and out of the workplace. Weve 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 whats next.

Grow with us

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