Microbiologist Technician

6 days ago


Pleasant Prairie, Wisconsin, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Microbiologist Technician to join our team at BioSpace, Inc. in a Second Shift role. As a key member of our Parenteral Operations team, you will be responsible for performing environmental monitoring of classified manufacturing areas and providing support for utility sampling and analysis within the manufacturing site.

Responsibilities
  • Perform environmental monitoring of classified manufacturing areas to ensure compliance with cGMP procedures and quality systems.
  • Provide support for utility sampling and analysis within the manufacturing site to ensure the quality and safety of our products.
  • Assist QC-Microbiology management with training and provide technical support to laboratory staff.
  • Participate in departmental continuous improvement projects and initiatives to improve processes and efficiency.
  • Author Standard Operating Procedures and Work Instruction documentation to ensure compliance with regulatory requirements.
Requirements
  • Associates degree or High School Diploma or equivalent.
  • 2+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
  • Demonstrated ability in performing environmental monitoring techniques, including viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water and clean steam collection and analysis.
Preferred Skills
  • Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
  • Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
  • Strong oral and written communication skills for communicating to colleagues, management, and other departments.
Work Environment

This is a night shift role, but requires flexibility to adjust schedule as needed to support the qualification and ongoing running of the area (24/7 operation). Ability to work 8 hour days - Monday through Friday. Ability to work overtime as required.

Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.



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