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

Sanofi; Ireland; Remote; EUR 55,000 - 75,000; Full time

Job summary

Sanofi Waterford is seeking a Process Engineer to join Fill Finish Fill Operations on a 24/7 shift with 12-hour rotations. You will lead batch release-related activities, support continuous improvement, and ensure compliance with GMP in sterile manufacturing.

Key responsibilities include investigations, CAPA, change controls, protocol generation, data reporting, and delivering KPI metrics within a high-regulation environment. On-site, on-going opportunities exist.

Qualifications

• Degree in engineering or related discipline.
• Strong problem-solving skills.
• Strong documentation, protocol generation and execution skills.
• Demonstrable experience in a highly regulated GMP environment.
• Experience in sterile manufacturing operations.

Responsibilities

• Own and deliver batch release-related activities for Fill Finish operations, including investigations, root cause analysis, CAPA generation and closure, work order investigations, and addressing batch comments from Quality.
• Support continuous improvement projects within thawing, formulation, filling, filter integrity testing, and wash/autoclave operations.
• Execute Process Engineering activities, including cycle development protocols and reports, project improvements, deviation management, problem solving, and change controls, ensuring compliance with quality and safety standards.
• Support commercial manufacturing through the delivery of key performance metrics (SQDCI).

Skills

Problem-solving

Documentation

Protocol execution

GMP experience

Sterile manufacturing

Education

Engineering degree

Job description

Sanofi Waterford is seeking a Process Engineer to join Fill Finish Fill Operations on a 24/7 shift with 12-hour rotations. You will lead batch release-related activities, support continuous improvement, and ensure compliance with GMP in sterile manufacturing.

Key responsibilities include investigations, CAPA, change controls, protocol generation, data reporting, and delivering KPI metrics within a high-regulation environment. On-site, on-going opportunities exist.