Associate Process Engineer - Gene Therapy Manufacturing

Forge Biologics; Columbus, Northern (OH, KY); Hybrid; USD 55,000 - 75,000; Full time

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

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.