Our client is a fast growing company active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Qualification & Validation, Quality Assurance, Consulting, Design Engineering and Construction Management.
With 15 employees/freelances and offices in Ghent, Mechelen and Anderlecht, the company 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.
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 could be our 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 (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
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
- 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 apply here or address your application, CV and a short motivation text, to us:
Mrs. Gwendoline de Robiano, email@example.com
With Reference « Permanent/Freelance CSV »
Never hesitate to contact us: +32 476 644 844
Only selected and Europe-based candidates will be contacted back by 3HR Recruitment Solutions, thanks for your understanding.