Process Engineer I, MS&T

Forge Biologics

Columbus (OH)

On-site

USD 70,000 - 100,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Annual bonus opportunities

401(k) with company match

Paid time off

Parental leave

Job summary

Forge Biologics seeks a Process Engineer I to support biopharmaceutical equipment and processes for gene therapy manufacturing. The role collaborates with Process Development, Manufacturing, MSAT, Validation, Quality, and external partners to ensure scalable, robust operations aligned with global regulatory expectations.

You will assist with engineering studies, documentation, and technology transfer activities while maintaining rigorous GMP documentation and process readiness in a highly

Qualifications

Bachelor’s degree in life sciences, engineering or related field with 2-3+ years of experience, or Master’s with 1+ year.
Foundational knowledge in drug substance/product manufacturing, process/utility equipment, or automated systems.
Ability to interpret technical docs (P&IDs, SOPs, vendor docs, manuals).
Strong organization and communication skills.
Commitment to SOPs, safety, and regulatory guidelines.

Responsibilities

Support engineering studies to evaluate equipment performance and optimize processes.
Assist drafting and revising engineering docs, SOPs, protocols, and reports.
Support technology transfer including process mapping and risk assessments.
Assist with FAT/SAT/IQ/OQ and vendor interactions under senior guidance.
Provide technical support for routine operations and equipment readiness.
Support investigations and corrective actions.
Ensure compliance with FDA, EMA, ICH and cGMP.

Skills

Tech knowledge basics

Documentation writing

Cross-functional collaboration

Attention to GMP docs

Education

Bachelor’s degree in life sciences, engineering or related field

Master’s degree (1+ years experience)

Tools

Electronic documentation systems

Job description

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.

Summary:

The Process Engineer I is a 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 of 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:

Bachelor’s degree, in life sciences, engineering or related field and 2-3+ years of experience, Master’s degree with 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.

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