Associate Process Engineer, MS&T

Responsibilities

• Support execution of engineering studies to evaluate equipment performance and optimize process parameters
• Assist with authoring and revising technical documentation including SOPs, protocols, and technical reports
• Support technology transfer activities including process flow mapping and risk assessments
• Support commissioning and qualification activities including FAT, SAT, and vendor IQ/OQ
• Support equipment troubleshooting and vendor interactions
• Provide technical support to Manufacturing for routine operations and new process implementation
• Support investigations related to process or equipment performance and corrective actions
• Ensure processes meet all regulatory guidelines (FDA, EMA, ICH) and cGMP requirements

Requirements

• Bachelor’s degree in life sciences, engineering, or related field with 1+ years of experience
• Master’s degree with 0-1+ years of experience
• Foundational technical knowledge in drug substance/product manufacturing or automated systems
• Ability to interpret technical documentation such as P&IDs, engineering drawings, and SOPs
• Strong organization and communication skills
• High attention to detail for accurate GMP documentation

Preferred Qualifications

• Prior experience in biologics or gene therapy manufacturing
• Familiarity with electronic documentation systems or data analysis tools

Benefits

• Health, dental, and vision insurance starting day one
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Onsite fitness facility
• Mental health counseling and financial planning services
• Fully stocked kitchen with free snacks and beverages

About the Company

Forge Biologics is dedicated to enabling access to life-changing gene therapies. Operating out of a state-of-the-art cGMP facility in Columbus, Ohio, the company partners with scientists and biotech innovators to bring cutting-edge therapies from idea to reality.