VALIDATION ENGINEER

GeelIFarmaceutische industrie

Functieomschrijving

The Validation Engineer, as part of the QA Validation team, will be responsible for the timely requalification of assigned systems. This may includes a large variety of systems, but will mainly be the typical biopharmaceutical processing systems (bioreactors, centrifuges, buffer/media vessels, chromatography columns, filtrations skids). Depending on business needs and internal resource planning, this scope can be expanded to utilities, HVAC, parts washers and autoclaves and qualification activities of a rather low complexity.
As a VALIDATION ENGINEER you will be working within the validation group responsible for large scale systems and cooperation with other departments (mainly manufacturing and technical services). 

As a VALIDATION ENGINEER you will have the following responsibilities:

  • Successful requalification of defined systems.
  • Reporting to the QA Validation Supervisor
  • Participate in the QA Validation team to successfully execute activities safely and to the expected level of quality, based on the overall RV schedule, for assigned systems.
  • Evaluate and, if applicable, update validation documents (URS, Impact Assessments) for assigned systems. The applied validation methodology is according to EU (Annex 15) and US (21CFR210/211/600) GMP regulations as well as specific internal company quality requirements.
  • Execute periodic review as part of the periodic system requalification
  • Generate requalification reports
  • Evaluate that design intent is met and proven throughout the system lifecycle, based on the outcome of the requalification exercises.
Profiel
  • You have a Master degree in a scientific or technical discipline (or equivalent by experience). 
  • You have at least basci knowledge of pharmaceutical plant qualification, preferably in a biotechnology process environment.
  • You have basic knowledge of process & clean utility design.
  • You understand the GMP requirements in EU and US for biotech operations (such as Eudralex, ICH, 21CFR) including area classifications (ISO 14644 and EU Annex 1).
  • You have operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.
  • You are fluent in Dutch and you are able to communicate and write in English.
  • You are results oriented with good organizational skills
Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

For one of our clients in the region of Geel we are looking for a VALIDATION ENGINEER 

Aanbod You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.
Heb je nog vragen?
Bénédicte Joret Business Unit Manager Life Sciences Select Projects +32 3 203 50 88
VALIDATION ENGINEER Vacature informatie
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