Forge Biologics

Forge Biologics

Process Engineer I, MS&T

Columbus, Ohio · Mid · Full-time

Sponsorship not specifiedDetected 1 day ago
Data AnalysisHRISCustomer SupportGMPFDA RegulatoryCRISPRCommunicationMentoring

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odds of building a lasting career here

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • 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.
  • 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.

Responsibilities

  • Support execution of 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.

Requirements

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

Skills

  • Your Future with Us:
  • to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • At Forge, your growth matters.

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.

Company info

  • 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.
  • Here, you won't just watch innovation happen - you'll be part of it.
  • 401(k) with company match to help you plan for the future.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.