The scope

Our client is a Belgian Engineering office active in Life Science Industries (Pharmaceutical and Biotechnology), with expertise in Qualification & Validation.

With 25 employees/freelances and offices in Belgium, the company is now looking for a Computerised System Validation Engineer for pharma projects in Wallonia.

Do you like working in a small business with a family ambiance?

Are you ready to contribute to their continued growth?

Do you have an entrepreneurial mindset and are you passionate about working in Life Science industries?

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

 

Your next challenge and responsibilities

As one of their 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 could be their ideal colleague if

• 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 experience in Life Sciences industries and industrial automation processes
• 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).
• 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
• ⚠ Only Europe-based and short-listed candidates will be invited for an interview, thanks for your understanding.

 

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
• Full time contract (40hr/wk + 12 RTT) and long term collaboration
• Location: in Wallonia Region (Belgium)
• Ideal start date: very asap
• Employee : A competitive salary
• Employee other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
• Freelance : a long term collaboration and evolving perspectives
• 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

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 address your application to Mrs. Gwendoline de Robiano, CV and a short motivation text + precise Permanent or Freelance.

 

⚠ Interested candidates need to have, at the time of application, the legal right to work in Belgium. We regret that we are not able to apply for work-permits on their behalf.  Only Europe-based and shortlisted candidates will be invited for an interview, thanks for your understanding.

 

Apply