US-FL-Clearwater: Scientist in biotech

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Date: 24-Mar-2009

Scientist II, Microbiology

Job Description This position is skill-set specific and necessary for day to day operations to include supervision of department and to sustain key areas of data collection, evaluation and verification related to microbiology.

Perform testing to international standards related to environmental monitoring, including particulate, viable counts, and water testing.

Perform QA activities such as in-house clean room validations and requalification and perform product bioburden engineering studies as required. Perform steam sterility validation activities and or coordinates testing with outside contractor.

Prepare monthly/quarterly summaries for environmental monitoring, bioburden and testing which includes trend analysis and maintaining data. Identify the local bioburden.

Assist management in OOS investigations and method/equipment validations.

Support the stability program.

Maintain laboratory equipment and supplies.

Review and approval of laboratory testing and documentation. This includes support of contract laboratory in microbiological and chemistry test methods and results as required. Qualifications BS in Biology, Microbiology preferred.

4 – 6 years experience in a related field. Two years supervisory experience preferred. Special Skills: Aseptic technique: Clean room monitoring and validation knowledge. Ability to develop sound scientific rationale for designing and execution of engineering studies and validation protocols. Specialized Training: ETO sterilization validation knowledge preferred but not required. Steam sterilization validation knowledge. Clean room monitoring and validation knowledge. Ability to develop sound scientific rational for designing and execution of engineering studies and validation protocols.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/