Technical Lead Qualifications Services

vor 4 Wochen

Darmstadt, Deutschland Cytiva Vollzeit

Be part of something altogetherlife-changing

Working atCytiva means being at the forefront of providing new solutions totransform human health. Our incredible customers undertakelife-saving activities ranging from fundamental biological researchto developing innovative vaccines, new medicines, and cell and genetherapies.

At Cytiva you willbe able to continuously improve yourself and us – working onchallenges that truly matter with people that care for each other,our customers, and their patients. With associates across 40+countries, Cytiva is a place where every day is a learningopportunity – so you can grow your career and expand your skills inthe long term.

Forming part ofthe Biotechnology segment at Danaher, we bring together dedicatedtechnical expertise and talent to develop the next generation oflife-changingtherapeutics.

TheTechnical Lead QualificationsServices (d/f/m) for Cytiva is responsiblefor creating content to help document the qualificationof Cytiva equipment on the customersite.

Thisposition is part of the Qualification Servicesteam and is located at the Dreieich facility inGermany and will be based onsite. AtCytiva, our vision is, to advance future therapeutics fromdiscovery todelivery.

Whatyou willdo:

  • Supportingproject management, automation and NPI team projects withinQualification Services (QS) business with creation and managementof technical aspects of master documenttemplates.

  • Manage and leadthe technical generation of content for multiple programs withinthe Qualification Servicesbusiness.

  • Creation ofquality Commissioning and Qualification (C&Q) documentationfrom system technical/design documents and guidance from subjectmatter experts.

  • Analysesoftware and hardware changes to determine impact on currentoffering or requirement for additionaltesting.

  • Support the broaderQS team in customer facingprojects.

Whoyouare:

  • Degreein Engineering or significant technical/quality servicebackground.

  • Familiarity with21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatorystandards. Minimum of 4 years of healthcareexperience.

  • Ability tounderstand and interpret technical productdocumentation.

  • Experienceworking within a QMS environment to ensure quality standards incommissioning and qualificationdocumentation.

  • Able to workwith a global team to meet project goals within agreedtimelines.

  • Fluent in spokenand written English, German is aplus

Travel,Motor Vehicle Record & Physical/EnvironmentRequirements:

  • Willingnessto travel globally, up to 25% of thetime

Itwould be a plus if you also possess previous experiencein:

  • Demonstratedcapability in performing execution of Commissioning andQualification of large complex custom and/or Flex FactoryProjects.

  • Understanding andexperience of field service actions for multiple Cytiva systemplatforms.

  • Experience increating and/or executing validation and verificationdocumentation.

#LI-onsite

AtDanaher we bring together science, technology and operationalcapabilities to accelerate the real-life impact of tomorrow’sscience and technology. We partner with customers across the globeto help them solve their most complex challenges, architectingsolutions that bring the power of science to life. Our global teamsare pioneering what’s next across Life Sciences, Diagnostics,Biotechnology and beyond. For more information, visit www.danaher.com.

AtDanaher, we value diversity and the existence of similarities anddifferences, both visible and not, found in our workforce,workplace and throughout the markets we serve. Our associates,customers and shareholders contribute unique and differentperspectives as a result of these diverseattributes.

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