Our client is a new Belgian Engineering Office founded by Experts and 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 a constant evolving team composed 15 employees/freelances and offices in Belgium, our client is now looking for 4 (freelance or Permanent) Commissioning, Qualification, Validation Engineers for pharmaceutical projects in Belgium and occasionally FAT abroad (mainly in BeNeLux and France, Germany and Switzerland).
This position is also open to high potential graduated and Junior Engineers (with at least an internship in QA or Validation or in a pharmaceutical industry).
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?
3HR Recruitment Solutions is the Recruitment Partner of Entrepreneurs and (very) small businesses, do you like working in a small business with a family ambiance?
We love meeting smart and forward-thinking talents, so don’t hold back!
Your key tasks and responsibilities
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 could be our ideal candidate if
- You hold a Training Certificate or 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 or you attended a training) in Life Sciences industries
- You have excellent communication skills in English + French or English + 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
- ⚠ Only Europe-based and selected candidates will be contacted back by 3HR Recruitment Solutions, 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 for Freelances and employees
- Full time mission or 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
- to employees : a permanent contract including 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 and address your application, CV and a short motivation text, to Mrs. Gwendoline de Robiano,
With Reference « Freelance/Permanent CQV Engineer »
⚠ Only Europe-based and selected candidates will be contacted back by 3HR Recruitment Solutions, thanks for your understanding.