Senior Microbiologist

What you will do:

• Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols.

• Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes.

• Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.

• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.

• Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.

• Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings

• Coordinates microbiological and/or chemical testing

• Review and approval quality records/ validations

• Troubleshooting/ NC Handling/ Supplier Management/ communication

• High Quality in Micro & Sterility

• Perform Monitoring Oversight / Data Trending

• Procedure Owners to Drive CAPAs/ Improvements

• Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP)

• Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility

• SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA

What you will need:

• Coordination, delegation, communication, stress, resiliency

• Relentless Quality First

• ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM)

• SME core competencies

• Product Cleanlines

• Cleanroom/ Environmental Monitoring/ Testin

• Sterilization (EO)

• English and German or French