Microbiologist

Microbiologist

Sanofi

Waterford, Ireland

About the job

As a Microbiologist, you will provide microbiological support in the QC microbiology lab and all support departments. This position includes performing microbiological and other testing following approved methodology to assure that the safety, quality, purity and stability (as appropriate) of our systems products, components and in-process stages are in compliance with approved specifications. Additionally, you will review test results, highlight problems related to technical and equipment issues, provide microbiological support to OOS results and work closely with the Senior Microbiologist/Microbiology Quality Leader.

The microbiology team is highly flexible and provides cross functional support. In this role, you will have opportunity to become multi skilled with the team and gain experience/skills within all areas essential to the running of a microbiology department.

Your role will also consist of supporting sterile manufacturing operations covering a 12/7 shift pattern.

Main responsibilities:

• Provide microbiological testing and support to the Microbiology and Manufacturing departments;
• Perform environmental monitoring within the sterile manufacturing area;
• Perform in process and finished product testing;
• Effective interaction with other departments (internal and external). In particular, close contact maintained with the Microbiology, Production, Validation, Manufacturing and Planning Departments, & QA;
• Execution of QC-Micro testing (water sampling, water testing, Biological Indicators, Endotoxin testing, Sterility testing and Environmental monitoring;
• Compliance with cGMP and Standard Operating Procedures at all times;
• Actively contribute to continuous improvement initiatives in the lab;
• QC Micro representation at cross functional meetings;
• Providing audit support;
• Supporting projects.

About you

Experience:

• Experience working within Microbiology in a GMP facility;
• Experience gained in pharmaceutical/biotechnology industry preferred.

Soft skills:

• Excellent communication skills;
• Natural influencer;
• Ability to work effectively in cross -functional teams.

Technical skills:

• Knowledge of quality management systems;
• Understand KPI’s for the site;
• Extensive knowledge of GMP in a regulated environment.

Education:

• Degree in Science or related area (Chemistry, Biochemistry, Microbiology or Pharmacy preferred).

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