Validation Specialist, Visp

Overview

MSAT Cleaning Validation Expert— Provide technical expertise and operational support for equipment cleaning validation activities to ensure GMP compliance, operational readiness, and regulatory inspection success. Sectors: Biopharmaceutical, Pharmaceutical Non-Negotiable Requirements

Proven experience in GMP cleaning validation within a biopharmaceutical or pharmaceutical manufacturing environment. Hands-on experience with equipment cleaning validation (e.g., COP, CIP, USP, DSP, buffer/media preparation systems). Experience authoring and reviewing validation protocols, reports, and GMP SOPs.Ability to perform and assess cleaning validation impact assessments for changes and deviations (DRs, CRs, TCRs). Degree in Life Sciences, Biotechnology, Chemical Engineering, or a related scientific discipline. Solid understanding of regulatory expectations (FDA, EMA) related to cleaning validation and contamination control.Experience supporting or participating in customer and regulatory inspections. Fluent in English (German is an advantage). Structured working style with strong documentation and data analysis skills. Ability to act as a technical subject matter expert and coordinate activities in a project environment.Responsibilities

Lead and execute equipment cleaning validation activities, including protocol and report authoring for COP, CIP, USP, DSP, and buffer/media preparation systems. Support and perform cleaning validation execution, including parts washer COP validation. Own and support the SOP lifecycle (authoring, review, update, and approval) related to cleaning validation.Coordinate with R&D, Manufacturing, QC, and QA on development and validation of new or modified cleaning processes. Ensure compliant implementation of validated cleaning methods in routine manufacturing operations. Act as technical lead and coordinator in cross functional projects related to cleaning validation. Provide cleaning validation impact assessments for deviations, changes, and technical change requests (DRs, CRs, TCRs).Contribute to customer and regulatory inspections, including preparation and presentation of validation data and rationale. Support evaluation of customer requests and inquiries related to cleaning validation topics. Interested? Apply now or send CV to

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