Validation Engineer

GeelIFarmaceutische industrie

Functieomschrijving Select Projects is looking for a Validation Engineer for a biopharmaceutical company in Geel.
As Validation Engineer you will be responsible for the qualification of designated systems (both utility and process). 

The role of the validation engineer will be one of direct responsibility, on behalf of Sanofi, for the successful qualifications of defined systems. (incl.  material certification, weld log/inspections, functional testing,.. where applicable).

Reporting to the validation Lead or manager, the role of the Validation engineer will be as follows:

Core responsibilities:
  • Write, review and approve validation & qualification protocols and reports, as well as execute protocols.
  • Familiarize oneself with all elements of the process & utility design for assigned systems. 
  • Perform Qualification activities in a GMP biotech manufacturing facility
  • Provide technical assistance to less experienced technicians/engineers.
  • Review/approve Qualification documentation (e.g. vendor test documentation/commissioning documentation) for assigned systems
  • Resolve protocol discrepancies and deviations.
  • Generate, review and approve deviations
  • Report & follow up on deviations, solving technical problems
  • Participate in risk assessments
  • Perform change control assessment
  • Overseeing activities performed by third parties
  • Engage with technical support functions (e.g. process, automation etc.) to resolve issues quickly as they arise through commissioning execution.
  • Report on progress - frequency as per requested by validation Lead.
Profiel Must haves:
  • At least least 3 years of experience in Qualification/validation
  • Degree of Masters Qualification in Science or Engineering
  • Knowledge of cGMP in a regulated 
  • Good knowledge of English and Dutch.
Nice to have:
  • Experience with the Kneat application
  • Knowledge of (use) DeltaV / BMS
  • Capability to work both independently and in a team environment
  • Strong analytical and communication skills
  • Strong interpersonal, organizational, and technical skills

.

Organisatie- en afdelingomschrijving At Select Projects, the customer's experience with our staff is key. It is our consultants who ensure an optimal experience by delivering the highest quality. Your professionalism is central to this and you can continue to grow at Select Projects so that you become and give the best version of yourself. As a consultant, you bring knowledge and skill and have the will to succeed. What is in return?

Select Projects offers substantively interesting projects, growth opportunities, autonomy, trust, training courses and expert colleagues you can learn from. This allows you to work fully on your professional growth and personal development.

At Select Projects, you are not only part of the team at the customer's site. You will also form a team with your fellow consultants in the field. We have family values where we help each other and pay attention to each other. This allows you to become and give the best version of yourself. Working at Select Projects means working on your craftsmanship and therefore being the specialist in your field.Aanbod Select Projects ensures that you end up in a pleasant working environment with fun colleagues where team spirit is key. We organise after-works, staff parties, sports events, team building, etc.

We offer you opportunities to develop and evolve. Together with you, we map out a training programme tailored to your future plans and needs. At Select Projects, you can become and give the best version of yourself.

In addition, Select Projects offers you a permanent contract of undetermined duration. You receive an attractive salary package including the following additional benefits:
  • Possibility of a company car with fuel card
  • Meal & eco vouchers
  • Expense allowance
  • Group & hospitalisation insurance
  • 12 ADV-days on an annual base
  • End-of-year bonus
  • Single and double holiday pay
  • Bonus system: collective bonus and individual bonus
  • Possibility to participate in Flex Income Plan
Heb je nog vragen?
Shona Bavalia Talent Acquisition Specialist 03 600 08 62
Validation Engineer Vacature informatie
109659
Biowetenschappen
Project sourcing
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