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CQV Lead Engineer

  1. Germany, East Germany
Leipzig
  1. Contract
Competitive
  1. Life Sciences
38005
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CQV Lead Engineer - Germany, Leipzig - 3 Months Initial 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:
  • Define and own the CQV strategy for the project
  • Develop and manage IQ/OQ protocols for equipment, utilities, and cleanroom areas
  • Review and finalise protocol drafts received from vendors and internal teams
  • Ensure all documentation is written in English
  • Lead execution of qualification protocols
  • Recommend and manage field-based CQV engineers for protocol execution if needed
  • Oversee qualification activities for: Equipment, Facilities, Utilities, Cleanroom environments
Requirements:
  • Proven experience leading CQV activities in a Drug Substance manufacturing environment
  • Strong background in utility system qualification and cleanroom re-qualification
  • Skilled in writing and executing streamlined qualification protocols
  • Ability to manage multiple validation streams and coordinate with field engineers
  • Familiarity with single-use systems and their qualification requirements
  • German language skills are a plus
  • Support single-use technology implementation and validation.
If this role is of interest to you, please apply now!

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