Sr. Engineer Technical Operations
XDES Projects
Leiden, NL
4 dagen geleden

Functie

The studies you’re working on must meet the quality requirements. This function encompasses cleaning, mixing and sterilization validation of production equipment.

  • You are responsible to maintain and continue to improve the validation process. This includes defining and developinng new validation strategies for the implementation of new equipment and NPIs.
  • You will train and coach engineers in GMP compliance and perform the internal review of protocols and reports.
  • You are responsible for preparation of protocols and execution of studies. Lead and support the coordination of studies.
  • You’ll participate in multidisciplinary projects as independent core team member to represent TO.
  • Assessment of change controls and preparing of validation assessments.
  • You lead and support in deviation investigations.
  • Functie eisen

  • Must have Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering).
  • Must have 3+ year relevant experience in the (bio-) pharmaceutical industry.
  • Precise, accurate, structured, flexible and customer focused.
  • Proven experience with GMP and compliance.
  • Expertise in process excellence and / or project management is a plus.
  • Good communicative skills in English language (writing and verbal), Dutch is considered a plus.
  • Aanbod

    A great role at a large pharmaceutical company.

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