Support Microbiology Expert

☞ Pauwels Consulting

看过: 102

更新日: 20-11-2025

位置: Beerse Antwerp

类别: 其他

行业: Staffing Recruiting

水平: Entry level

工作类型: Full-time

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工作内容

PDMS Microbiology is central service partner within Janssen providing global support in the field of microbiology for clinical Small Molecule and Large Molecule programs, as well as Lifecycle Management programs.

Amongst others, responsibilities of the department include specification setting for drug product, finished products, drug substances, excipients, packaging materials, and in process controls, developing and implementing the global method qualification/validation approach, ownership of global test methods and transfers thereof, etc.

General Mission

  • Responsible for leading and coordinating R&D & Lifecycle Management projects
  • Review and approval of development reports, qualification/validation reports, test methods (sterility, microbial purity, ATP bioluminescence, bioburden, bacterial endotoxin, PET/AET, etc.)
  • Transfer of PDMS-owned test methods to Janssen sites and external contract laboratories
  • Coordination, assessment and follow up of Change Controls (CC’s) in the field of microbiology
  • Review / approval of specification documents
  • Ensure compliance with the GMP requirements
  • Responsible for the overall quality and compliance (guidelines, J&J requirements) and ensures that work adheres to established (GMP) operating procedures, legal H&S and environmental regulations adhering to company work standards.

What are we looking for?

Knowledge & Skills

  • Profound knowledge of pharmaceutical regulations/GxP principles (FDA, EU, …), general knowledge of pharmaceutical manufacturing processes, product development.
  • Self-motivated hands-on mentality
  • Efficiently establishes priorities, checkpoints and timeframes for assigned work in support of objectives and team projects.
  • Works independently on assignments and reports efficiently to management
  • Escalates issues in timely and concise manner to management
  • MSc or PhD degree relevant to pharmaceutical microbiology, or a bachelor degree with proven track record demonstrating required experience.
  • Competency in professional/scientific English
  • Ability to master different software packages.
  • Experience with Trackwise and Docspace is an asset
  • Experience in GMP environment is an asset
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最后期限: 04-01-2026

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