• Are you a structured, conscientious, and precise fast learner?
• Are you a real team player who can also work independently?
• Do you have a CAN-DO mentality who can think proactively?
• Do you have the knowledge and practical experience of the latest developments in the CSV (Computer system validation) and cGMP.

We love meeting smart and forward-thinking talents, so don’t hold back!

• You will broaden your knowledge of current industry standards, regulatory requirements, and Authority expectations regarding CSV.
• You will develop a project-specific CSV approach and methodology.
• You will prepare project CSV deliverables:
  • User Requirement Specifications
  • Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
  • Validation Master Plan (VMP)
  • Design Review/Qualification
  • Test Matrices
  • FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
• You will support the project schedule for CSV activities.
• You will organize, execute and document CSV testing.
• You will support during system/installation start-up in the function of CSV test activities.
• You will set up and follow up of Project documentation System and Management.
• You will work in close collaboration with Project, Engineering, and CQV Management.

The projects are mainly situated in the Life science/Biotech Industry:

• Vaccines: m-RNA, viral vector, mAbs…
• Cell/gene/protein therapies
• DS/DP/Formulation/Filling

The projects consist of the following packages/discipline:

• Facilities: HVAC, cleanroom finishes, Interlock, EMS,
• Clean Utilities production, storage and distribution (WFI, PW, PS, clean gasses)
• Prim. & Sec. Process equipment: bioreactors, filter systems, autoclaves , decontamination systems, ….
• Filling systems
• Automation and process control

We are looking for different people in different regions:

• Wallonia
• East/West Flanders and Antwerp
• Limburg, Kempen and adjacent Netherlands

The CSV Engineer has proven record of

• a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in automation-regulation, IT or relevant other expertise.
• a significant experience in Life Sciences industries and industrial automation processes.

The CSV Engineer has

• excellent communication skills in English, French and/or Dutch (written and spoken).
• an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations ( Eudralex , FDA, PICS, ICH, ISO, ASTME2500, ….).
• a good comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
• knowledge of the latest developments in the C&O field and relevant legislation and industry standards (cGMP).
• a field experience with:
  • Scada, supervision and computerized system
  • IT regulation
  • Computerized System Validation