Demo

Microbiologist II

Greiner
Monroe, MI Full Time
POSTED ON 3/17/2025
AVAILABLE BEFORE 4/8/2025

Your challenge

  • Perform Microbiological testing and examination according to valid procedures, such as Biobuden, Endotoxin, Sterility, Growth Promotion, and Environmental Monitoring.
  • Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
  • Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
  • Assist in the development of facility gowning program.
  • Act as an SME for method validation for new products.
  • Author SOPs, test procedures, and assist in creating validation protocols and reports for the lab.
  • Data entry for trends and reporting on them for management review.
  • Intrepretation of sterilization dose audit results and elevation of the data trends as needed.
  • Test non-conforming product to resolve QIR issues as well as investigate returned products via complaint processing system.
  • Assist in investigations along with other departments to identify root cause.
  • Completion of assigned CAPA as needed.
  • Coduct aspetic technique training and Hygiene regulation training for other departments.
  • Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
  • Purchase requestion and material transfer in SAP.
  • Coordination of sample testing via external / third-party vendor(s).
  • Communication and information exchange with affiliated Greiner facilities.
  • Other duties as assigned.

Your Profile

  • Minimum Bachelor’s or Master’s Degree in microbiology, or related field.
  • Minimum 3 years of relevant work experience in GMP-controlled laboratory environment.
  • Experience in Medical Device, Pharmaceutical, and / or regulated industry is preferred.
  • Basic Knowledge of medical device regualtion,industry,and international standards.
  • Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
  • Knowledge of gamma and ebeam sterilization, and ISO 11137 requirements.
  • Physical Requirements :

  • Must be able to stand and walk for up to 8 hours.
  • Must be able to lift up to 70 lbs.
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