Technical Lead Qualifications Services Specialist

vor 4 Wochen

Darmstadt, Hessen, Deutschland Cytiva Vollzeit
About the Role

We are seeking a highly skilled Technical Lead Qualifications Services to join our team at Cytiva. As a key member of our Qualification Services team, you will be responsible for creating content to help document the qualification of Cytiva equipment on the customer site.

Key Responsibilities
  • Support project management, automation, and NPI team projects within Qualification Services (QS) business with creation and management of technical aspects of master document templates.
  • Manage and lead the technical generation of content for multiple programs within the Qualification Services business.
  • Creation of quality Commissioning and Qualification (C&Q) documentation from system technical/design documents and guidance from subject matter experts.
  • Analyse software and hardware changes to determine impact on current offering or requirement for additional testing.
  • Support the broader QS team in customer-facing projects.
Requirements
  • Degree in Engineering or significant technical/quality service background.
  • Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of healthcare experience.
  • Ability to understand and interpret technical product documentation.
  • Experience working within a QMS environment to ensure quality standards in commissioning and qualification documentation.
  • Able to work with a global team to meet project goals within agreed timelines.
  • Fluent in spoken and written English, German is a plus.
What We Offer
  • Opportunity to work with a global team to meet project goals within agreed timelines.
  • Chance to develop and lead technical content for multiple programs within the Qualification Services business.
  • Collaborative and dynamic work environment.
About Cytiva

Cytiva is a leading provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. We bring together science, technology, and operational capabilities to accelerate the real-life impact of tomorrow's science and technology.

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