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CSV Engineer

Sanofi Ireland
Closing date
20 Mar 2023

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CSV Engineer- Digital Twin and Packaging/ Serialisation

Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland's southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology.

Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences.

We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.



  • In depth knowledge of the requirements for Computerised Systems and supporting system design.
  • Full interpretation of GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice - Products for Human and Veterinary Use, Annex 11: Computerised Systems. [21 CFR Part 11] Food and Drug Administration Code of Federal Regulations - Electronic Records, Electronic Signatures, Final Rule. General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
  • Competent at coaching, oversight & decision making on complex CSV issues and associated support systems.
  • You show strong leadership skills and demonstrate the ability to work in cross-functional teams.
  • You are trained as a GMP auditor to support internal GxP audits of computerised systems.


  • Lead qualification of (MES) Manufacturing Execution System and associated outbound and inbound system
  • Maintain validation philosophies, master plans and procedures required to drive the validation lifecycle of production recipes
  • * Work in conjunction with Validation team, Production, Manufacturing Engineering and Quality Assurance to manage program and strategies aligned with site validation philosophies
  • Establish validation plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with stakeholders


The role will require:

  • Project support - Digital Twin
  • Packing and Site Serialisation support
  • Site support
  • BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required
  • Minimum of 5 + years of experience with MES (Manufacturing Execution Systems) (Werum Pas-x) pharmaceutical process systems executing design, commissioning, troubleshooting activities is required
  • Working knowledge of cGMP type systems and practices is required
  • Strong foundation of Industrial Automation and Manufacturing IT Systems
  • Computer System Validation (CSV) Experience 5+


Apply today or contact myself at [email protected] for further information.


Sanofi Ireland has 800 people working every day to serve those with health needs in Ireland and around the world. Wherever the team members are based, they all share the values of Teamwork, Integrity, Courage and Respect and their  common purpose:  Empowering Life.

Their manufacturing campus in Waterford has more than 740 skilled people working across multiple products and platforms, supplying therapies to people in over 70 countries. Sanofi continue to expand, providing opportunities for people to join the team, and help us support their No1 stakeholders; the people we provide our medicines for. 

Their dedicated team based out of Dublin bring a broad range of treatments to people across Ireland. Amongst our treatments we have consumer healthcare, vaccines, and medicines for cardiovascular disease, diabetes, multiple sclerosis, thrombosis, rare diseases and atopic dermatitis.

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