Senior CQV Engineer for pharmaceutical projects throughout Belgium

Description de fonction

Your key tasks and responsibilities

As one of their 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

Description du profil

You could be our ideal candidate if

• You hold a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in biotechnology, industrial, pharma, chemical sciences or relevant other expertise
• You have a significant experience (min. 4 years) in Life Sciences industries
• You have excellent communication skills in English + French 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
• You have a B driving licence
• ⚠ Only Europe-based and selected candidates will be contacted back by 3HR, thanks for your understanding.

Nous offrons

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 job in a dynamic and knowledge-sharing network company
• Full time contract
• Location: Flexible depending to clients’ locations
• A competitive salary or rate
• Other benefits for employees including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
• 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

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

We are looking forward to meeting you soon.  

Your application

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

If this is you, please apply here addressing your application, CV and a short motivation text, to Mrs. Gwendoline de Robiano

⚠ Only Europe-based and selected candidates will be contacted back by 3HR Recruitment Solutions, thanks for your understanding.

All our vacancies are daily updated on www.3HR.be