Automation project Engineer (GxP / OT-IT Integration)

Consultant – Automation Project Engineer (GxP / OT-IT Integration)

About the role

We are looking for an Automation Project Engineer (Consultant) with OT or IT experience in a regulated (GxP) environment. You will represent the Automation function within project teams and implement automation solutions that enable digital connectivity between equipment and enterprise systems, bridging the OT and IT domains.

The systems are typically located in the OT layer (ISA-95 levels 1–3), while interacting with systems managed by the IT organization. You will work with GxP-qualified systems and, in addition to project work, provide technical support for live systems, including participation in an on-call service.

Key responsibilities

Project delivery

• Own and manage the automation scope within a multidisciplinary project team

• Design OT/IT integration solutions and connectivity approaches

• Configure and implement computerized systems

• Request and/or procure required hardware and software

Commissioning, validation & compliance

• Develop, review, and execute documentation to implement, maintain, operate, and validate automated GxP systems, including:

  • (Commissioning) protocols

  • Test plans

  • Reports

  • Technical and compliance documentation

Operational support

• Troubleshoot issues, perform root cause analysis, and propose solutions

• Provide weekend on-call support (09:00–17:00)

• Support investigations, deviations, and CAPAs through to timely, compliant closure

• Communicate proactively with project leads and key stakeholders

Required knowledge & experience

• Prior experience with OT or IT systems in a GxP environment

• Understanding of computer networking and industrial layering concepts (e.g., ISA-95)

• Knowledge of GxP requirements relevant to automation (e.g., ALCOA/ALCOA+ and EU GMP Annex 11)

• Basic scripting / programming skills (preferred: PowerShell/CMD and SQL)

Nice to have

• Cybersecurity knowledge (including NIS2)

• Experience with industrial automation technology and validation standards in the pharmaceutical industry

Mindset & ways of working

• Prioritizes quality (ALCOA+) and safety in every decision

• Strong organizational skills: self-organized, able to coordinate work with minimal direction

• Comfortable working under pressure in a structured, compliant environment

• Proactive team player with a service mindset

Education

• Degree in Computer Science, Applied Engineering (Electronics & ICT), or equivalent experience

Years of experience

• 4+ years of relevant experience

Languages

• English: fluent (written and spoken)

• Dutch: C1 level preferred