Forge Biologics

Forge Biologics

Associate Process Engineer, MS&T

Columbus, Ohio · Full-time

Sponsorship not specifiedDetected 15 days ago
Data AnalysisHRISCustomer SupportGMPFDA RegulatoryCRISPRCommunicationMentoring

About the role

  • 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.
  • 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 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.
  • 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.
  • Build collaborative working relationships with internal stakeholders to drive the business towards achieving company objectives.
  • Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Requirements

  • Bachelor's degree, in life sciences, engineering or related field and 1+ years of experience, Master's degree with 0-1+ years of experience
  • Demonstrated basic ability to interpret and utilize technical documentation including engineering drawings, piping and instrumentation diagrams (P&IDs), SOPs, vendor documentation, and equipment manuals.
  • 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.
  • 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.

Nice to have

  • 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.
  • We've Got You Covered:

Compensation

  • We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Benefits

  • Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
  • 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.
  • Annual bonus opportunities for all full-time team members.
  • 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.
  • Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
  • Onsite fitness facility at The Hearth.

Company info

  • 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.

Equal opportunity

  • Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce.
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