CH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Vollzeitmit HomeofficeSenior
Visp
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LOLonza
MSAT Cleaning Expert(m/w/x)
Visp
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
You will ensure the highest quality standards by managing complex cleaning validation activities and technical assessments, serving as a key expert during critical inspections and audits.
Anforderungen
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in biopharma cleaning or cleaning validation
- Experience in cGMP-regulated biopharmaceutical environment
- Understanding of biologics manufacturing and cleaning regulatory requirements
- Proven experience in managing complex projects
- Ability to manage multiple tasks and meet deadlines
- Exposure to process development or manufacturing (advantageous)
- Experience engaging with regulatory agencies (advantageous)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English; German is an advantage
- Ability to work on site in Visp 60% of the time
Aufgaben
- Develop and coordinate equipment cleaning activities
- Collaborate with operations, QA, and QC teams
- Implement validated cleaning methods in routine manufacturing
- Prepare and organize project-specific cleaning documentation
- Conduct technical assessments of carryover for cleaning
- Review and approve buffer cleaning validation reports
- Manage clean and dirty hold time documentation
- Perform annual cleaning reviews of the facility
- Coordinate troubleshooting and support deviation investigations
- Approve non-conformity records and change requests
- Serve as the primary counterpart for validation experts
- Represent the facility as a cleaning SME during audits
Berufserfahrung
ca. 1 - 4 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – Grundkenntnisse
Tools & Technologien
cGMPmammalian manufacturing processbiologics manufacturing processMSATQualityprocess developmentupstream/downstream processesscale-upmammalian cell cultureSwissmedicFDA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- CH12 Lonza AG
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LOLonza
MSAT Cleaning Expert(m/w/x)
Visp
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
You will ensure the highest quality standards by managing complex cleaning validation activities and technical assessments, serving as a key expert during critical inspections and audits.
Anforderungen
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in biopharma cleaning or cleaning validation
- Experience in cGMP-regulated biopharmaceutical environment
- Understanding of biologics manufacturing and cleaning regulatory requirements
- Proven experience in managing complex projects
- Ability to manage multiple tasks and meet deadlines
- Exposure to process development or manufacturing (advantageous)
- Experience engaging with regulatory agencies (advantageous)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English; German is an advantage
- Ability to work on site in Visp 60% of the time
Aufgaben
- Develop and coordinate equipment cleaning activities
- Collaborate with operations, QA, and QC teams
- Implement validated cleaning methods in routine manufacturing
- Prepare and organize project-specific cleaning documentation
- Conduct technical assessments of carryover for cleaning
- Review and approve buffer cleaning validation reports
- Manage clean and dirty hold time documentation
- Perform annual cleaning reviews of the facility
- Coordinate troubleshooting and support deviation investigations
- Approve non-conformity records and change requests
- Serve as the primary counterpart for validation experts
- Represent the facility as a cleaning SME during audits
Berufserfahrung
ca. 1 - 4 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – Grundkenntnisse
Tools & Technologien
cGMPmammalian manufacturing processbiologics manufacturing processMSATQualityprocess developmentupstream/downstream processesscale-upmammalian cell cultureSwissmedicFDA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Noch nicht perfekt?
- CH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Vollzeitmit HomeofficeSeniorVisp - CH12 Lonza AG
Senior Quality Excellence Manager(m/w/x)
Vollzeitmit HomeofficeSeniorVisp - Arxada
Head of Indirect Procurement NCE(m/w/x)
Vollzeitmit HomeofficeSeniorVisp - Lonza
EMEA Intercompany Sales Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel, Visp - AFRY
Projektingenieur:in Strassen- und Bahnbau(m/w/x)
Vollzeitmit HomeofficeManagementBrig-Glis