Microbiologist - Sterilization - Contractor
Our client, a leading Medical Device organisation in Stuttgart Germany are looking to recruit a Microbiologist - Sterilization Contractor on an hourly rate basis.
What will I be doing?
- Working with Engineers to design protocols to ensure that new products/ product packing changes are adequately tested with respect to biological and sterilization requirements to guarantee compliance to all regulatory standards.
- Attending project meetings.
- Preparing on AGILE protocols for validation of new products/ product packaging changes, executing the testing and completing the reports.
- Preparing on AGILE protocols for validation/ revalidation and dose audits of sterilization processes executing the testing and completing the reports.
- Liaising with manufacturing and R&D engineers to obtain test samples.
- Liaising with test laboratories to issue test details for testing required and to receive test results.
- Ensuring that all required testing is completed in a timely manner and reports approved to meet project timelines.
- Supporting the Regulatory Affairs department in preparing submissions to notified bodies and addressing any questions regarding these submissions.
- Generating AGILE change requests to update sterilization validation documentation.
- Reviewing all applicable regulatory standards to ensure that requirements are reflected in internal documentation and implementing changes when standards are revised.
- Performing quality audits of external contactors.
- Supporting audits of sterilization area performed by internal auditors or notified bodies.
- Gathering of information for support problem-solving of sterilization validation related issues.
- A Science qualification to degree level is essential, further post graduate study in a related discipline would be of benefit.
- Excellent verbal and written communication skills are essential for this role; a good working knowledge of process validation requirements would be beneficial.
- A minimum of 2 years' experience in a related area is required. Some training will be given.
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