With a constant evolving team composed by employees and freelances and offices in Ghent, PhénX is now looking for a Commissioning, Qualification, 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 CQV Engineers, you will

• Have a knowledge of current Industry standards, regulatory requirements and Authority expectations regarding CQV
• Develop project specific CQV approach and methodology
• Prepare project CQV 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 CQV activities
• Organise, execute and document CQV testing
• Support during system/installation start-up in function of CQV test activities
• Set up and follow up of Project documentation System and Management
• Work in close collaboration with Project, Engineering and Construction Management
• Be in charge of the registration of quality indicators for CQV Engineer’s discipline

• You hold a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in bio, industrial, pharma, chemical or relevant other expertise
• You have a significant (or a first experience) in Life Sciences industries
• 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).
• You have a field experience with:
  • System start-up and CQV
  • Project scheduling
  • Change management
  • Project document management
• You are a structured, conscientious and 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 CQV Engineer »