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Validation EngineerProgressive • Leiden, South Holland, Netherlands
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Validation Engineer

Validation Engineer

Progressive • Leiden, South Holland, Netherlands
22 dagen geleden
Functieomschrijving

Validation Engineer MSAT - Biotherapeutics Drug Substance


For an international pharmaceutical organization, we are looking for an Engineer MSAT Validation. In this role, you will be part of the Manufacturing Science & Technology (MSAT) team and play a key role in supporting process validation activities within a growing biotherapeutics manufacturing environment.


  • Location: Leiden region, Netherlands
  • Hours: Full-time
  • Contract Duration: 12 months (with the possibility of extension)


Responsibilities:

  • Plan and coordinate Supporting Process Validation (SPV) activities
  • Execute validation activities related to mixing, buffer hold time, microbial hold time, and moist heat sterilization processes
  • Write and review validation documentation, including protocols and reports
  • Support projects as the responsible team member for performance qualification activities
  • Execute performance qualification activities in support of the site change control program
  • Contribute to process improvements, benchmarking, and standardization initiatives
  • Ensure compliance with GMP requirements and company procedures


Requirements:

  • Master's degree in a relevant field such as (Bio)Chemical Engineering or Biotechnology with 0-2 years of relevant experience, or a Bachelor's degree with 2+ years of relevant experience
  • Experience within the biopharmaceutical industry or relevant academic experience
  • Knowledge of GMP and data integrity principles, including ALCOA+
  • Understanding of validation and qualification processes within the pharmaceutical industry
  • Strong communication, planning, documentation, risk management, and problem-solving skills
  • Fluent in English


Preferred:

  • Experience with mixing validation, buffer hold time, microbial hold time, and moist heat sterilization qualification
  • Experience with Lean, Six Sigma, or similar continuous improvement methodologies
  • Dutch language skills


Interested or know someone who could be a great fit? Contact me directly at f.dol@progressive-nl.com or apply here!

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Validation Engineer • Leiden, South Holland, Netherlands

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