Process Engineer in Fill Finish Fill Operations 24 7

Sanofi; Waterford; On-site; EUR 65,000 - 85,000; Full time

Job summary

Sanofi in Waterford, Ireland is hiring a Process Engineer in Fill Finish Fill Operations for a 23-month fixed term contract. The role is on-site with a 24/7 shift pattern (2 days, 2 nights, 4 days off, 12-hour shifts) and requires leading batch release activities and process improvements.

You will work within GMP-compliant sterile manufacturing, handle investigations, CAPA, deviations, and change controls, and support metrics delivery while developing within a global biopharma network.

Qualifications

• 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.

Responsibilities

• Own batch release activities for Fill Finish operations, incl. investigations, CAPA, and batch comments resolution.
• Support CI projects across thawing, formulation, filling, filter integrity testing, and wash/autoclave ops.
• Execute process engineering activities: cycle development, reports, improvements, deviations, problem solving, and change controls with GMP/safety compliance.
• Support manufacturing by delivering KPIs (SQDCI).

Skills

Engineering degree

Problem solving

Documentation

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.

Ready to get started?

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.

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