With 20 employees/freelances and many clients in Belgium, the company is now looking for an experienced Computerised System Validation Engineer (Freelance or Employee) for pharmaceutical projects in Belgium with very occasional travels abroad (mainly in BeNeLux and France, Germany and Switzerland). This position is also open to high potential graduated and Junior Engineers.
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 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, ideally min. 3 years in CSV
- You have excellent communication skills in English and French OR in English and 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
- A full time contract 40hr/week + 12 RTT/yr : Freelance or Employee
- 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
- For employees: 32 days off/yr., a competitive salary and other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
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 apply here or address your application, CV and a short motivation text, to us:
Mrs. Gwendoline de Robiano with Reference « Permanent/Freelance CSV Engineer »
REM: Only short-listed and Europe-based candidates will be invited for an interview, thanks for your understanding.