With a constant evolving team composed by employees and freelances and offices in Ghent, PhénX is now looking for a Computerised System Validation Engineer for pharmaceutical projects in Belgium and occasionally abroad (mainly in BeNeLux and France, Germany and Switzerland). This position is also open to high potential graduated and Junior Engineers.

As one of our CSV Engineers, you will

• Have a knowledge of current Industry standards, regulatory requirements and Authority expectations regarding CSV
• Develop project specific CSV approach and methodology
• 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
• Support in project schedule for CSV activities
• Organise, execute and document CSV testing
• Support during system/installation start-up in function of CSV test activities
• Set up and follow up of Project documentation System and Management
• Work in close collaboration with Project, Engineering and CQV Management

• You hold a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in automation-regulation, IT or relevant other expertise
• You have a significant (or a first experience) in Life Sciences industries and industrial automation processes
• You have excellent communication skills in English, French and/or Dutch (written and spoken)
• You have an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations (Eudralex, FDA, PICS, ICH, ISO, ASTME2500 …)
• You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry
• You know the latest developments in the C&Q field and relevant legislation and industry standards (cGMP).
• Technical expertise in engineering, electricity or automation
• You have a field experience with:
  • Scada, supervision and computerized system
  • Experience in IT regulation
  • Experience in Computerised System Validation
  • Familiar with IT/IS systems
• You are structured, conscientious and a precise fast-learner
• You are a real team player who can also work independently
• You are ready to travel and you are flexible on schedules and duties
• You are resourceful with a CAN DO mentality who can think proactively

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
• 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

Would you like to work for a small company with a top level service?

We are looking forward to meeting you soon.

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 « Permanent CSV Engineer »