VALIDATION SUPPORT

Heist-op-den-BergIPharmaceutical Sector

Job description

For one of our pharmaceutical clients in Heist-op-den-Berg we are currently looking for a Validation Support Engineer.

In this position, you will be working within the scope of sterilization validation and cleaning validation.

Sterilization validation support:

  • Providing support to several sterilization projects (development & validation) and periodic re-qualifications.
    Sterilization methods that are involved:
    • Steam sterilization via autoclave and Steam In Place
    • Dry heat sterilization/depyrogenation via oven and tunnel
    • Gas decontamination via Vaporized Hydrogen Peroxide
    • Radiation sterilization via gamma beams
  • Coordinating the different activities together with validation, production and laboratories:
    • Making appointments with production and laboratories
    • Calibration of thermosensors
    • Preparation of validation loads
    • Creation of LIMS requests
    • Execution of studies
    • Evaluation study data results
  • Managing the stock of used test tools (thermosensors, biological indicators, auxiliary)
  • Housekeeping of the validation laboratory
  • Writing and updating procedures or work instructions within the scope of the activities

Cleaning validation support:

  • Providing support to several cleaning projects (development & validation) and periodic re-qualifications.
    Cleaning methods that are involved:
    • Partswashers
    • Clean In Place
    • Manual
  • Coordinating the different activities together with validation, production and laboratories:
    • Making appointments with production and laboratories
    • Creation of LIMS requests
    • Execution of studies
    • Evaluation study data results
  • Managing the stock of used test tools (swabs, auxiliary)
  • Housekeeping of the validation laboratory
  • Performing periodic reviews of the different processes under the responsibility of the Tech Ops department to control the validated state
  • Providing support to the monitoring program for potential cross contamination of active compounds by sampling non-product contact surfaces per approved protocols
Profile

Your profile: 

  • You have a Bachelor in Chemistry/Biology/Biomedical oriented studies or equivalent through experience
  • You possess relevant experience in sterilization processes and qualification
  • You have the ability to implement theoretical technical knowledge into practice and to use this knowledge in a technical environment
  • You have good knowledge of English (talking/writing/reading)
  • You are very communicative and diplomatic
  • You are a true team player
  • You are motivated to work in a challenging environment
  • You are interested in daily work on the shopfloor
  • You have a quality and scientific mindset
  • You work action-oriented and autonomously
  • The working hours are during the day, however some activities are also being performed at the production shop floor, thus working in an early/late shift is possible (exceptional during night/weekend shift)
Organisation and department description

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.

Offer

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.

Any questions?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
VALIDATION SUPPORT Vacancy information
71042
Life Science
Project Sourcing
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