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
- Perform gap analysis, facility fit studies, process safety assessments, and risk analyses for new product introductions.
- Monitor and analyze process data during manufacturing to identify trends and support issue resolution.
- Assist in development and optimization of manufacturing processes for new and existing products.
- Prepare, update, and maintain specifications, protocols, procedures, transfer plans, and manufacturing batch records related to NPI activities.
- Provide operational technical support, including troubleshooting during drug product fill-finish operations.
- Lead and/or assist risk assessments such as PFMEA and EHS evaluations.
- Assist and/or lead investigations, change plans, and process-related problem solving.
- Support, supervise, and train manufacturing personnel for NPI and drug product processes.
- Work closely with global science, quality, MS&T, and development groups on process development and technical transfer.
- Ensure adherence to EHS standards, cGMP expectations, HPRA/FDA requirements, and site procedures.
- Support cross-functional teams and cost-improvement initiatives, providing technical expertise to daily operations.
- Operate with high autonomy and escalate significant decisions to the NPI Technical Manager when required
- Provide technical support for drug product fill-finish operations for biologics products.
- Support processes involving lyophilized drug product.
- Lead or support technical transfer deliverables, including gap assessments and cleaning assessments.
- Work with drug product processes designed with single-use technologies.
Requirements
- Third-level degree in a relevant engineering, science, or technical discipline (required).
- Master’s qualification in a relevant technical discipline (desirable).
- Minimum 3 years’ experience in pharmaceutical process engineering with exposure to batch processing, scale-up, technical transfers, and cGMP biologics or pharmaceutical operations (desirable).
- Experience with new product introductions to biologics facilities (desirable).
- Minimum 1 year in a similar role and minimum 1 year within pharmaceutical or biologics industries.
- Strong technical and operational knowledge of unit operations in a fill-finish facility.
- Proven problem-solving skills, innovative thinking, strong attention to detail, and commitment to quality.
- Strong communication and interpersonal skills with ability to influence and lead cross-functional activities.
- Ability to prioritize work, operate independently, and ensure Right First Time execution.
- Demonstrated ownership, accountability, and adherence to EHS and regulatory compliance.
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