Entry-Level Process Engineer, Biotech Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Parental leave

401(k) with company match

Onsite fitness facility

Employee discounts

Mental health resources

Fully stocked kitchen

Professional development

Job summary

Forge Biologics in Columbus, OH is seeking an Associate Process Engineer to support biopharmaceutical equipment and processes used in gene therapy manufacturing. You’ll collaborate with Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure scalable, compliant operations.

This entry-level role emphasizes hands-on learning, documentation, and troubleshooting under senior staff, with mentorship and growth opportunities across manufacturing science

Qualifications

• Foundational technical knowledge in drug substance/product manufacturing.
• Ability to interpret engineering drawings, P&IDs, SOPs, vendor docs, and equipment manuals.
• Strong organization and communication skills.
• Attention to detail and GMP documentation.
• Commitment to following SOPs and regulatory guidelines.

Responsibilities

• Support execution of engineering studies to evaluate equipment performance and process parameters.
• Assist with authoring and revising technical documentation (studies, SOPs, protocols, reports).
• Support technology transfer activities including process mapping and risk assessments.
• Assist commissioning/qualification activities (URS, FAT, SAT, IQ/OQ).
• Provide troubleshooting support and vendor interactions under guidance.
• Offer technical support to Manufacturing for routine operations and new processes.
• Support investigations related to process or equipment performance and corrective actions.
• Ensure processes meet regulatory guidelines (FDA, EMA, ICH) and cgMP requirements.
• Build collaborative relationships with internal stakeholders to achieve objectives.
• Demonstrate professional behavior per company policies and values.

Skills

GMP documentation

Technical knowledge

Engineering drawings

Communication skills

Education

Bachelor’s degree in life sciences or engineering

Master’s degree with 0-1+ years of experience

Job description

Forge Biologics in Columbus, OH is seeking an Associate Process Engineer to support biopharmaceutical equipment and processes used in gene therapy manufacturing. You’ll collaborate with Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure scalable, compliant operations.

This entry-level role emphasizes hands-on learning, documentation, and troubleshooting under senior staff, with mentorship and growth opportunities across manufacturing science