Validated Systems Engineer
Validated Systems Engineer voor een GMP-gereguleerde productieomgeving, on-site in Breda, tijdelijk via SIRE Life Sciences.
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
Eisen
- Structured approach to troubleshooting, documentation and continuous improvement
- Up to 4 years of relevant experience in manufacturing, IT/OT, automation or application support
- Motivation to learn and work within GMP/validated manufacturing environments
- Professional working proficiency in English
- Strong communication skills and ability to work effectively with both technical and operational teams
- Bachelor’s degree in IT, Automation, Engineering or a comparable technical discipline
Wensen
- Exposure to packaging/labelling systems, SCADA, industrial networks, system integrations, and/or qualification/testing/change control
Volledige omschrijving
Our client is a global, innovation-driven organisation operating in a highly regulated manufacturing environment. The site focuses on reliable delivery of critical products and works to high quality and compliance standards. Teams collaborate closely across Manufacturing, Quality, Engineering and Technology to improve processes and keep operations running smoothly. We are looking for a Validated Systems Engineer to strengthen the Operations Technology team in Breda.
This position sits at the intersection of digital technology and the production floor, helping to improve reliability, efficiency and compliance of packaging and labelling operations. The Validated Systems Engineer will support and improve a defined set of manufacturing systems (including SCADA and system integrations), working with site stakeholders and global teams to deliver practical solutions in a GMP-regulated environment.
Responsibilities include: supporting the design, testing, qualification and change-control of manufacturing systems in line with GMP requirements and site procedures; maintaining and troubleshooting a portfolio of operational manufacturing systems to ensure stable day-to-day performance; working with cross-functional stakeholders (Manufacturing, Quality, Engineering and Technology) to identify issues, root causes and improvement opportunities; supporting implementations and continuous improvement initiatives around packaging and labelling technology (e.g., SCADA, authentication solutions, mobile workstations and label-printing integrations); creating clear documentation and training users on new or updated processes and systems; escalating and collaborating with internal experts and external technology partners when needed, and following through until resolution; taking increasing ownership of systems and deliverables over time, with guidance from experienced engineers and subject-matter experts; and providing occasional flexibility outside standard hours to support planned go-lives or critical operational issues.
Requirements include a Bachelor’s degree in IT, Automation, Engineering or a comparable technical discipline; up to 4 years of relevant experience in manufacturing, IT/OT, automation or application support; a structured approach to troubleshooting, documentation and continuous improvement; strong communication skills and ability to work effectively with both technical and operational teams; professional working proficiency in English; and motivation to learn and work within GMP/validated manufacturing environments.
Nice to have: exposure to packaging/labelling systems, SCADA, industrial networks, system integrations, and/or qualification/testing/change control. This is an on-site role based in Breda, close to the manufacturing environment, combining project implementation with continuous improvement and operational support. If you are interested and want to apply, please submit your application via the apply button below and contact me.
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