Drug Product Process Engineer
Job Title & Summary
The Drug Product Process Engineer supports drug product fill-finish operations, new product introductions, and technical transfers within a GMP biologics facility. The role provides technical expertise, process monitoring, and hands-on support to ensure safe, compliant, and efficient manufacturing.
Responsibilities
1. Perform gap analysis, facility fit studies, process safety assessments, and risk analyses for new product introductions.
2. 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.
Requirements
17. Third-level degree in a relevant engineering, science, or technical discipline (required).
18. Master's qualification in a relevant technical discipline (desirable).
19. Minimum 3 years' experience in pharmaceutical process engineering with exposure to batch processing, scale-up, technical transfers, and cGMP biologics or pharmaceutical operations (desirable).
20. Experience with new product introductions to biologics facilities (desirable).
21. Minimum 1 year in a similar role and minimum 1 year within pharmaceutical or biologics industries.
22. Strong technical and operational knowledge of unit operations in a fill-finish facility.
23. Proven problem-solving skills, innovative thinking, strong attention to detail, and commitment to quality.
24. Strong communication and interpersonal skills with ability to influence and lead cross-functional activities.
25. Ability to prioritize work, operate independently, and ensure Right First Time execution.
26. Demonstrated ownership, accountability, and adherence to EHS and regulatory compliance.
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