Forge Biologics
Associate Process Engineer, MS&T
- Confirmed live in the last 24 hours
- No salary listed
- Entry level
- On-site · Columbus, Ohio
- 1+ yrs exp
- Added 1 month ago
About this role
Forge Biologics seeks an Associate Process Engineer to support the implementation and upkeep of equipment and processes vital to gene therapy manufacturing. This collaborative role works with various teams to ensure processes are scalable, robust, and compliant with regulatory standards. You’ll contribute to engineering studies, technical documentation, and troubleshooting efforts within a state-of-the-art cGMP facility.
What you'll do
- Execute engineering studies to evaluate equipment performance and optimize processes.
- Assist in creating and updating technical documentation (SOPs, protocols, reports).
- Support technology transfer activities and risk assessments.
- Assist with commissioning and qualification (FAT, SAT, IQ/OQ).
- Support equipment troubleshooting and vendor communication.
- Provide technical support to Manufacturing teams.
What they're looking for
- Biopharmaceutical Equipment
- Process Engineering
- Technical Documentation
- cGMP
- Regulatory Guidelines (FDA, EMA, ICH)
- Troubleshooting
- Process Flow Mapping
- Risk Assessment
Benefits
- Hands-on Learning
- Opportunities for Advancement
- Collaborative Work Environment
- Work in a state-of-the-art facility
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Forge Biologics
- Industry
- Biotech & Pharma
Likely interview questions
- Describe your experience with GMP documentation and its importance in biopharmaceutical manufacturing.
- How would you approach troubleshooting an unexpected deviation in a manufacturing process?