Job Title: Process Engineer
Description:
Our company is seeking a talented Drug Product Process Engineer to support our fill-finish operations, new product introductions, and technical transfers within a GMP biologics facility.
1. The successful candidate will perform gap analysis, facility fit studies, process safety assessments, and risk analyses for new product introductions.
2. They will monitor and analyze process data during manufacturing to identify trends and support issue resolution.
3. Assist in development and optimization of manufacturing processes for new and existing products.
4. Prepare, update, and maintain specifications, protocols, procedures, transfer plans, and manufacturing batch records related to NPI activities.
5. Provide operational technical support, including troubleshooting during drug product fill-finish operations.
6. Lead and/or assist risk assessments such as PFMEA and EHS evaluations.
7. Assist and/or lead investigations, change plans, and process-related problem solving.
8. Support, supervise, and train manufacturing personnel for NPI and drug product processes.
9. Work closely with global science, quality, MS&T, and development groups on process development and technical transfer.
10. Ensure adherence to EHS standards, cGMP expectations, HPRA/FDA requirements, and site procedures.
11. Support cross-functional teams and cost-improvement initiatives, providing technical expertise to daily operations.
12. Operate with high autonomy and escalate significant decisions to the NPI Technical Manager when required.
13. Provide technical support for drug product fill-finish operations for biologics products.
14. Support processes involving lyophilized drug product.
15. Lead or support technical transfer deliverables, including gap assessments and cleaning assessments.
16. Work with drug product processes designed with single-use technologies.