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LILilly

Associate Director - Validation TS/MS(m/w/x)

Alzey
Full-timeOn-siteSenior
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Sterilization and cleaning validation for life-changing medicines. Extensive validation and team leadership experience required. Accommodation for individuals with disabilities, equal employment opportunities.

Requirements

  • BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
  • Understanding of GMPs and manufacturing processes
  • Experience in building and leading a team
  • Extensive knowledge of equipment qualification and/or cleaning, decontamination, sterilization process validation
  • Strong knowledge of risk management and ability to use risk assessment tools as part of validation strategy
  • Ability to analyze complex data and solve problems
  • Strong technical writing and presentation skills
  • Fluent in English
  • English Resume only
  • Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)
  • Able to communicate in German

Tasks

  • Maintain a safe work environment
  • Support HSE corporate and site goals
  • Build and lead a team aligned with Lilly values
  • Plan and execute sterilization validation
  • Conduct cleaning validation
  • Perform filter validation
  • Execute shipping validation
  • Complete temperature mapping
  • Develop robust revalidation systems
  • Coordinate with engineering, operations, and quality
  • Ensure correct governance for validation activities
  • Manage stakeholders and leadership team
  • Align with operational planning
  • Coach team for technical development
  • Own validation concepts
  • Ensure network alignment
  • Investigate complex validation deviations
  • Guide product impact assessments
  • Review completed validation packages
  • Compile and analyze validation data
  • Manage external contracts and resources
  • Present validation topics during inspections
  • Stay updated on validation requirements
  • Follow industry best practices
  • Benchmark within the Lilly network

Work Experience

  • approx. 4 - 6 years

Education

  • Master's degree

Languages

  • English – Fluent
  • German – Basic

Benefits

Other Benefits

  • Accommodation for individuals with disabilities
  • Equal employment opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lilly and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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