Process Engineer I, Biologics & Gene Therapy

Forge Biologics; Columbus (OH); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Annual bonus opportunities

401(k) with company match

Paid time off

Parental leave

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Tech knowledge basics

Documentation writing

Cross-functional collaboration

Attention to GMP docs

Educación

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

Master’s degree (1+ years experience)

Herramientas

Electronic documentation systems

Descripción del empleo

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