Job Description

Work Flexibility: Hybrid

What you will do:

  • Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and entoxin testing.

  • Review/writing of cleaning protocols and reports in line with ISO 19227 standards

  • Oversight of EtO sterilization processes. Validation and monitoring in line with ISO 11135

  • Oversight of radiation sterilization processes. Validation and monitoring in line with ISO 11137

  • Interpreting sampling and monitoring data, appliying statistical and analysis techniques, to determine control and trending. Indentifies and initiates when to take action.

  • Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.

  • Act as tech...

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