MSAT Cleaning Validation Expert
m/w/d, Wallis
We are looking for an MSAT expert who is experienced in planing and performing cleaning validation in the biopharmaceutical industry!
Your 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.
Your background:
* Degree in Life Sciences, Biotechnology, Chemical Engineering, or a related scientific discipline.
* Experience authoring and reviewing validation protocols, reports, and GMP SOPs.
* Strong cross functional collaboration skills, working with MSAT, QA, QC, Manufacturing, and R&D.
* Hands on experience with equipment cleaning validation (e.g. COP, CIP, USP, DSP, buffer/media preparation systems).
* Solid understanding of regulatory expectations (FDA, EMA) related to cleaning validation and contamination control.
* Ability to perform and assess cleaning validation impact assessments for changes and deviations (DRs, CRs, TCRs).
Das klingt nach einer spannenden Position?
Dann freuen wir uns über vollständige Bewerbungsunterlagen per Onlineformular.
Bei Bewerbungen per E-Mail erklärt sich der Sender respektive die Senderin damit einverstanden, dass die übermittelten Daten unter Berücksichtigung unserer Datenschutzrichtlinie verwendet werden.
Weitere offene Stellen gibt es hier: coopers.ch
Job Profil (WZQ556)
* Life Sciences - Engineering Plant
* Wallis
* Contracting
* Vollzeit
* cleaning validation, Msat
Klingt interessant?
Einfach "Jetzt bewerben" klicken, dann melde ich mich.
Larissa Birkle
Talent Acquisition Consultant
+41 61 633 30 67
larissa.birkle@coopers.ch