Process Engineer (24/7)

Sanofi; Waterford; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sanofi in Waterford, Ireland is seeking a Process Engineer for a 23-month fixed-term contract on-site. You will lead batch release activities for Fill Finish, drive improvement projects across manufacturing steps, and ensure adherence to GMP standards.

This role requires a degree in engineering and strong problem-solving and documentation skills. You will collaborate with operations to deliver robust process engineering solutions, manage deviations and change controls, and contribute to key

Qualifications

• Requires a degree in engineering and strong problem-solving abilities.
• Demonstrates robust documentation, protocol generation and execution skills.
• Experience in highly regulated GMP environments is essential.
• Experience in sterile manufacturing operations is advantageous.

Responsibilities

• Own batch release-related activities and support Fill Finish operations
• Lead continuous improvement initiatives across thawing, formulation, filling, testing, and wash/autoclave processes
• Perform process engineering activities: develop protocols/reports, manage deviations and change controls
• Provide key performance metrics for manufacturing with SQDCI emphasis

Skills

Problem solving

Documentation

Protocol execution

GMP experience

Sterile manufacturing

Education

Bachelor's degree in Engineering

Job description

Job Title: Process Engineer

• Shift: 24/7 - 2 Days, 2 Nights, 4 Days Off (12-hour Shifts)

• Shift: 24/7 - 2 Days, 2 Nights, 4 Days Off (12-hour Shifts)
• Location: Waterford, Ireland
• Job Type: 23-month Fixed Term Contract
• Work Arrangement: On-site

About The Role

As a Process Engineer with Sanofi you will provide leadership and support to operations teams to ensure appropriate standards are met. The role will involve the development and implementation of improvement initiatives in all manufacturing and development operations.

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Own and deliver batch release-related activities to support Fill Finish 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
• 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.
• Support commercial manufacturing through the delivery of key performance metrics (SQDCI).

About You

• Degree in an Engineering discipline.
• Strong problem-solving skills.
• Strong documentation, protocol generation and protocol execution skills.
• Demonstrable relevant experience in a highly regulated GMP environment.
• Experience in Sterile Manufacturing Operations.

Beneficial But Not Essential

• Batch release experience.
• Experience in syringe and/or vial filling and inspection would be a distinct advantage.

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting‑edge technology, ensuring seamless launches and a resilient global supply.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross‑functional roles, and work in an environment that values growth and discovery.