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Msat cleaning validation expert

Visp
Manpower Basel
Inserat online seit: Veröffentlicht vor 12 Std.
Beschreibung

MANPOWER AG – Your career, our focus!Become part of our network and take advantage of countless opportunities!ManpowerGroup is the world's leading company for workforce solutions.With our three brands – Manpower, Experis, and Talent Solutions – we support companies from various industries with their recruitment needs. For 75 years, we have been operating in over 75 countries and accompany our clients throughout Switzerland to successfully carry out their tasks and projects.MSAT Cleaning Validation ExpertAbout the RoleWe 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 ResponsibilitiesLead and execute cleaning validation activities for manufacturing equipment and associated systemsPrepare, review and finalise validation protocols, reports and GMP-relevant documentationSupport cleaning validation execution for systems such as COP, CIP, USP, DSP and buffer/media preparation equipmentPerform and support parts washer COP validation activitiesManage the SOP lifecycle for cleaning validation topics, including authoring, review, updates and approval coordinationCollaborate with R&D, Manufacturing, QC and QA on the development, optimisation and validation of new or modified cleaning processesEnsure validated cleaning methods are implemented compliantly within routine manufacturing operationsAct as technical SME and coordinator for cross-functional cleaning validation projectsConduct cleaning validation impact assessments for deviations, change requests and technical change requests, including DRs, CRs and TCRsSupport customer and regulatory inspections by preparing, explaining and presenting validation data, rationale and documentationEvaluate customer requests and inquiries related to cleaning validation topicsEnsure consistency and appropriate oversight of cleaning validation activities across BioAtriumRequired ProfileDegree in Life Sciences, Biotechnology, Chemical Engineering or a comparable scientific disciplineProven experience in GMP cleaning validation within a pharmaceutical or biopharmaceutical manufacturing environmentHands-on experience with equipment cleaning validation, ideally including COP, CIP, USP, DSP and buffer/media preparation systemsStrong understanding of FDA and EMA expectations related to cleaning validation, contamination control and GMP complianceExperience writing and reviewing validation protocols, reports and GMP SOPsAbility to assess cleaning validation impact in the context of deviations, changes and technical requestsExperience supporting or participating in customer audits and regulatory inspectionsStrong documentation skills and a structured, detail-oriented working styleGood analytical skills and ability to interpret validation dataStrong cross-functional collaboration skills and confidence working with MSAT, QA, QC, Manufacturing and R&DAbility to act as a technical subject expert in a project-driven environmentFluent English skills; German is an advantageAssignment DetailsLocation: Visp, SwitzerlandWorkload: Full-timeWork model: On-siteContract duration: Until 31 December 2026Extension: Possible extension of 1 monthEnvironment: GMP-regulated biopharmaceutical manufacturing siteKarrierestufeBerufserfahrenBrancheBiotechnologieforschungBeschäftigungsverhältnisVollzeitTätigkeitsbereicheQualitätssicherungKenntnisse und FähigkeitenGute Herstellungspraxis (GMP)Analytische FähigkeitenDokumentationInspektionReinigungsvalidierungFertigungQualitätssicherungEnglisch jid0d860d4a jit0418a jiy26a

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