Process Engineer, Pre-Filled Syringe Manufacturing

Biopharma Careers; Waterford; On-site; EUR 55,000 - 73,000; Part time

Job summary

Sanofi is seeking a Process Engineer for its Waterford, Ireland site to support pre-filled syringe manufacturing from a GMP perspective. The role focuses on batch release, process improvements, and technology transfer across sterile operations with emphasis on quality systems and CAPA closures.

You will contribute to ongoing NPI initiatives, capacity expansions, and continuous improvement projects while collaborating with an integrated Engineering Team in a highly regulated environment.

Qualifications

• Degree in an Engineering discipline.
• Proven problem-solving and documentation skills in GMP environments.
• Experience in sterile manufacturing operations.

Responsibilities

• Own and deliver batch release-related activities for PFS Fill Operations, including investigations, root cause analysis, CAPA generation and closure, work order investigations, and addressing batch comments from the Quality team.
• Support continuous improvement projects within thawing, formulation, filling, filter integrity testing, and wash/autoclave operations to support New Product Introduction (NPI) and capacity expansion initiatives including but not limited to single-use technology vendor selection, component introduction, and qualification activities.
• Execute Process Engineering activities, including cycle development protocols and reports, project improvements, deviation management, problem solving, and change controls, ensuring compliance with applicable quality and safety standards.
• Provide Process Engineering support for the existing aseptic syringe filling line, including Debagger, Ebeam, Delid, Deline, Isolator, and syringe filling equipment utilizing multiple filling technologies.
• Support commercial manufacturing through the delivery of key performance metrics (SQDCI).

Skills

Problem solving

Documentation

GMP experience

Sterile manufacturing

Education

Engineering degree

Job description

Sanofi is seeking a Process Engineer for its Waterford, Ireland site to support pre-filled syringe manufacturing from a GMP perspective. The role focuses on batch release, process improvements, and technology transfer across sterile operations with emphasis on quality systems and CAPA closures.

You will contribute to ongoing NPI initiatives, capacity expansions, and continuous improvement projects while collaborating with an integrated Engineering Team in a highly regulated environment.