MSAT Cleaning Validation Expert

About the Role

We are looking for an experienced MSAT Cleaning Validation Expert to support equipment cleaning validation activities within a GMP-regulated biopharmaceutical manufacturing environment in Visp.

In this role, you will provide technical expertise, ensure compliant validation documentation, support operational readiness, and contribute to successful customer and regulatory inspections. You will work closely with MSAT, QA, QC, Manufacturing and R&D to ensure that cleaning validation processes are robust, inspection-ready and aligned with regulatory expectations.

Key Responsibilities

• Lead and execute cleaning validation activities for manufacturing equipment and associated systems
• Prepare, review and finalise validation protocols, reports and GMP-relevant documentation
• Support cleaning validation execution for systems such as COP, CIP, USP, DSP and buffer/media preparation equipment
• Perform and support parts washer COP validation activities
• Manage the SOP lifecycle for cleaning validation topics, including authoring, review, updates and approval coordination
• Collaborate with R&D, Manufacturing, QC and QA on the development, optimisation and validation of new or modified cleaning processes
• Ensure validated cleaning methods are implemented compliantly within routine manufacturing operations
• Act as technical SME and coordinator for cross-functional cleaning validation projects
• Conduct cleaning validation impact assessments for deviations, change requests and technical change requests, including DRs, CRs and TCRs
• Support customer and regulatory inspections by preparing, explaining and presenting validation data, rationale and documentation
• Evaluate customer requests and inquiries related to cleaning validation topics
• Ensure consistency and appropriate oversight of cleaning validation activities across BioAtrium

Required Profile

• Degree in Life Sciences, Biotechnology, Chemical Engineering or a comparable scientific discipline
• Proven experience in GMP cleaning validation within a pharmaceutical or biopharmaceutical manufacturing environment
• Hands-on experience with equipment cleaning validation, ideally including COP, CIP, USP, DSP and buffer/media preparation systems
• Strong understanding of FDA and EMA expectations related to cleaning validation, contamination control and GMP compliance
• Experience writing and reviewing validation protocols, reports and GMP SOPs
• Ability to assess cleaning validation impact in the context of deviations, changes and technical requests
• Experience supporting or participating in customer audits and regulatory inspections
• Strong documentation skills and a structured, detail-oriented working style
• Good analytical skills and ability to interpret validation data
• Strong cross-functional collaboration skills and confidence working with MSAT, QA, QC, Manufacturing and R&D
• Ability to act as a technical subject matter expert in a project-driven environment
• Fluent English skills; German is an advantage

Assignment Details

• Location: Visp, Switzerland
• Workload: Full-time
• Work model: On-site
• Contract duration: Until 31 December 2026
• Extension: Possible extension of 1 month
• Environment: GMP-regulated biopharmaceutical manufacturing site

• Karrierestufe

  Berufserfahren

• Branche
  • Biotechnologieforschung
• Beschäftigungsverhältnis

  Vollzeit

• Tätigkeitsbereiche
  • Qualitätssicherung
• Kenntnisse und Fähigkeiten
  • Gute Herstellungspraxis (GMP)
  • Analytische Fähigkeiten
  • Dokumentation
  • Inspektion
  • Reinigungsvalidierung
  • Fertigung
  • Qualitätssicherung
  • Englisch

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