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Validation Lead

  1. Germany, Central Germany
Bielefeld
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36754
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Validation Lead - North Rhine-Westphalia, Norway - 6-12 Months Contract

This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process.

Responsibilities:
  •  This hire will be responsible for managing the entire validation element of this project. 
  • Validation of:
    • Equipment
    • Facilities
    • Utilities
    • Clean room
Requirements:
  • Ideally German speaking.  English speaking is a prerequisite.
  • Experience of owning the validation element of a project, defining the strategy, and writing the Validation Master Plan (VMP)
  • Experience of writing validation protocols (currently none are written, and they anticipate needing 10-12 for the equipment).
  • Experience of writing streamlined validation protocols.
  • Experience of executing the protocols.
  • Technical experience: Drug Substance – downstream processing; conjugation, purification, molecular, bacterial, peptides.  Previously supporting validation activities in this manufacturing environment is essential.
  • The ability to communicate to suppliers and internally is essential.
  • Ideal experience: Single use technology.
If this role is of interest to you, please apply now!
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