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LILilly

Quality Control Microbiologist(m/w/x)

Alzey
Full-timeOn-siteExperienced

Routine microbiological testing of raw materials, in-process samples, and finished products. 3-5 years GMP microbiology lab experience required. Company pension plan, well-being benefits.

Requirements

  • Bachelor's or Master's degree in Microbiology, Biology, Biochemistry, or related life sciences
  • 3–5 years hands-on experience in GMP microbiology lab
  • Proficiency in microbiological testing, aseptic practices, environmental monitoring
  • Familiarity with LIMS (MODA, SmartLab) and quality systems (TrackWise)
  • Knowledge of cleanroom operations, contamination control, cGMP regulations
  • Understanding of ALCOA+ data integrity and good documentation
  • Proficiency in German and English (written and oral)
  • Strong attention to detail, problem-solving, analytical skills
  • Ability to work independently and collaboratively
  • Flexibility for shifts, weekends, and overtime

Tasks

  • Perform routine microbiological testing
  • Conduct sterility, endotoxin, bioburden, and microbial identification tests
  • Test raw materials, in-process samples, finished products, water, and gases
  • Execute environmental monitoring activities
  • Sample viable and non-viable air, surfaces, personnel, water, and compressed gases
  • Support laboratory setup and qualification activities
  • Participate in Environmental Monitoring Performance Qualification (EMPQ)
  • Conduct Pre-Approval Readiness (PAR) cycles
  • Validate Clean Utilities PQ and CIP/SIP protocols
  • Operate and maintain laboratory equipment and EM instruments
  • Calibrate air samplers, particle counters, incubators, autoclaves, and analytical instruments
  • Prepare and maintain microbial stock cultures, growth media, reagents, and consumables
  • Manage laboratory inventory and material qualifications
  • Document accurately in LIMS and electronic systems
  • Ensure data integrity with ALCOA+ principles and GDP
  • Identify and investigate deviations, OOS results, and environmental excursions
  • Participate in root cause analysis (RCA)
  • Implement corrective and preventive actions (CAPA)
  • Create, review, and revise SOPs, protocols, work instructions, trend reports, and technical documentation
  • Coordinate external laboratory testing
  • Submit samples, review results, and oversee contract laboratory activities

Work Experience

  • 3 - 5 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • MODA
  • SmartLab
  • TrackWise

Benefits

Competitive Pay

  • Competitive salary

Retirement Plans

  • Company pension plan

Mental Health Support

  • Individual benefits for well-being

Other Benefits

  • Individual benefits for financial security
  • Workplace accommodation for individuals with disabilities
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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