Our client is a new Engineering office active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Qualification & Validation, Quality Assurance, Consulting, Engineering and Construction Management.
With a constant evolving team composed 15 employees/freelances and offices in Belgium, our client is now looking for a (Junior or Medior) Commissioning, Qualification, Validation Engineer for working on COVID-19 vaccines R&D and later Production in Belgium and very occasionally abroad (FAT 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 Commissioning or in a pharmaceutical industry).
Are you ready to contribute to their continued growth?
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?
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 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, a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in bio, industrial, pharma, chemical, Life Sciences or relevant other expertise
- You have a significant (or a first experience) 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 and evolving position on exciting projects
- An internal mentoring system between Junior and Senior Consultants
- Full time contract or freelance mission
- Location: Flexible depending on clients’ locations and depending on your home address
- 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 : a competitive salary + other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription and 32 days off/year
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 addressing your application, CV and a short motivation text, to Mrs. Gwendoline de Robiano
With Reference « Permanent/Freelance* Junior/Medior* Covid-19 CQV » (* please precise)
! Only Europe-based and selected candidates will be contacted back by 3HR Recruitment Solutions, thanks for your understanding.