Associate Process Engineer, MS&T New Columbus, Ohio

Forge Biologics

Columbus, Northern (OH, KY)

Hybrid

USD 55,000 - 75,000

Full time

5 days ago

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Benefits offered by this job

Health, dental and vision insurance (初

Paid time off

12 weeks parental leave

Annual bonus opportunities

401(k) with company match

Onsite fitness facility

Employee assistance program

Snacks and beverages

Professional development

Job summary

Forge Biologics seeks an Associate Process Engineer to support biopharmaceutical equipment and processes for gene therapy manufacturing at our Columbus facility. You will assist with technical transfers, engineering studies, and troubleshooting under senior engineer guidance to ensure readiness and scale-up readiness.

This entry-level role emphasizes collaboration with Process Development, Manufacturing, MSAT, Validation and Quality to maintain compliant operations and robust processes.

Qualifications

Bachelor’s degree in life sciences or engineering and 1+ years of experience.
Foundational technical knowledge in drug substance/product manufacturing or related equipment.
Ability to read and interpret engineering drawings, P&IDs, SOPs and vendor manuals.
Commitment to following SOPs, safety protocols and regulatory guidelines.

Responsibilities

Support engineering studies to evaluate equipment performance and optimize processes.
Assist with drafting and revising technical documentation (engineering studies, SOPs, protocols, reports).
Support technology transfer activities including documentation and risk assessments.
Assist commissioning/qualification activities (URS, FAT, SAT, IQ/OQ) and vendor interactions.
Provide technical support to Manufacturing for new processes and equipment readiness.
Support investigations related to process or equipment performance.
Ensure compliance with FDA/EMA/ICH and cGMP quality systems.
Collaborate with cross-functional teams to achieve company objectives.
Uphold professional behavior per company policies and values.
Additional responsibilities may be assigned as needed by management.

Skills

Organization skills

Communication skills

Attention to detail

Regulatory compliance

GMP documentation

Education

Bachelor’s degree in life sciences or engineering

Master’s degree in related field

Tools

Engineering drawings

P&IDs

SOPs

Vendor documentation

Electronic documentation systems

Data analysis tools

Job description

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 ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, 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

TheAssociate Process Engineer 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 managemen

Qualifications

Bachelor’s degree, inlife sciences, engineering or related field and 1+ years of experience, Master’s 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.

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.

Work Environment and Physical Demands

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.

Health from day one

Health, dental and vision insurance start your first day – with 90% of premiums covered for youand 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.
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