Process Engineer in Fill Finish Fill Operations 24 7

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

Job Title: Process Engineer in Fill Finish Fill Operations, 24/7

Location: Waterford, Ireland

Job Type: 23-month Fixed Term Contract

Work Arrangement: On-site

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

About t he 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.

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€54800,00 - €73067 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.