Process Engineer — 24/7 Fill/Finish GMP Ops (On-site)

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

Job summary

Sanofi in Waterford, Ireland is seeking a Process Engineer for Fill Finish Operations. The role involves leading batch release activities, investigations, CAPA, and change controls within a 24/7 (12‑hour) on-site operation.

The ideal candidate holds an engineering degree and strong GMP/sterile manufacturing experience, with a focus on continuous improvement across processing steps to ensure quality and compliance.

Qualifications

• Degree in an Engineering discipline.
• Strong problem-solving abilities demonstrated in regulated environments.
• Experience in a highly GMP-regulated setting.
• Experience in sterile manufacturing operations.

Responsibilities

• Own and deliver batch release-related activities for Fill Finish Operations, including investigations and CAPA.
• Support continuous improvement projects across thawing, formulation, filling, and related processes.
• Execute process engineering tasks including protocols, reports, deviations and change controls.
• Support commercial manufacturing with key performance metrics (SQDCI).

Skills

Problem-solving

Documentation skills

GMP experience

Sterile manufacturing

Education

Engineering degree

Job description

Sanofi in Waterford, Ireland is seeking a Process Engineer for Fill Finish Operations. The role involves leading batch release activities, investigations, CAPA, and change controls within a 24/7 (12‑hour) on-site operation.

The ideal candidate holds an engineering degree and strong GMP/sterile manufacturing experience, with a focus on continuous improvement across processing steps to ensure quality and compliance.