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Our client, a global leader in the production and process support of active pharmaceutical ingredients in both the chemical and biotechnology sectors, is seeking a MSAT Cleaning Validation Expert based in Visp (Switzerland) for a 6 months contract position with the possibility of extension.
The purpose of the role is to provide technical expertise and operational support for equipment cleaning validation activities to ensure GMP compliance, operational readiness, and regulatory inspection success at BioAtrium.
Main responsibilities:
1. Lead and execute equipment cleaning validation activities, including protocol and report authoring for COP, CIP, USP, DSP, and buffer/media preparation systems.
2. Support and perform cleaning validation execution, including parts washer COP validation.
3. Own and support the SOP lifecycle (authoring, review, update, and approval) related to cleaning validation.
4. Coordinate with R&D, Manufacturing, QC, and QA on development and validation of new or modified cleaning processes.
5. Ensure compliant implementation of validated cleaning methods in routine manufacturing operations.
6. Act as technical lead and coordinator in cross functional projects related to cleaning validation.
7. Provide cleaning validation impact assessments for deviations, changes, and technical change requests (DRs, CRs, TCRs).
8. Contribute to customer and regulatory inspections, including preparation and presentation of validation data and rationale.
9. Support evaluation of customer requests and inquiries related to cleaning validation topics.
10. Ensure appropriate oversight and consistency of cleaning validation activities across BioAtrium.
Qualifications and Experience:
11. Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.
12. Degree in Life Sciences, Biotechnology, Chemical Engineering, or a related scientific discipline.
13. Proven experience in GMP cleaning validation within a biopharmaceutical or pharmaceutical manufacturing environment is a must.
14. Hands on experience with equipment cleaning validation (e.g. COP, CIP, USP, DSP, buffer/media preparation systems) is mandatory.
15. Solid understanding of regulatory expectations (FDA, EMA) related to cleaning validation and contamination control is required.
16. Ability to perform and assess cleaning validation impact assessments for changes and deviations (DRs, CRs, TCRs) is a must.
17. Experience authoring and reviewing validation protocols, reports, and GMP SOPs.
18. Strong cross functional collaboration skills, working with MSAT, QA, QC, Manufacturing, and R&D.
19. Experience supporting or participating in customer and regulatory inspections.
20. Structured, detail oriented working style with strong documentation and data analysis skills.
21. Ability to act as a technical subject matter expert and coordinate activities in a project environment.
22. Fluent in English (German would be an advantage).