CSV Engineer

The PHENX team creates pragmatic CQV/CSV solutions for the Life Science Industry. With a constant evolving team composed by employees and freelances and offices in Ghent, PhénX is now looking for CSV Engineer

We’re not just looking for anyone

  • 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!

The challenges we take on as a team

  • 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

Who are we looking for

  • 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

We offer you

Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues, who have a professional attitude and attach considerable importance to teamwork.
We stand for:

  • a challenging position
  • a full time contract
  • location: Flexible depending to clients’ locations
  • a challenging job in a dynamic and knowledge-sharing network company
  • the freedom to develop yourself in line with your ambition
  • a great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
  • a competitive salary
  • other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription

Who are we?

We are a close team of multidisciplinary solutions finders. We are result and human-focused

Our differentiators?

  • Our broad and thorough knowledge
  • Our creativity
  • Our adaptability
  • Our accessible

What makes us stronger

  • Team cohesion
  • Transparency
  • Operational excellence


We’re looking for motivated and passionate individuals who love to build things and solve problems.

If this is you, please address your application,

CV and a short motivation text, to us:

hr@phenx.be with Reference « CSV Engineer »

or call +32 479 / 98 46 69.