CH12 Lonza AG
Senior Quality Excellence Manager(m/w/x)
Vollzeitmit HomeofficeSenior
Visp
Neuer Job?Nejo!
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CHCH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Visp
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing process validation strategies, authoring protocols, and conducting hold time/resin lifetime assessments at global biopharma leader. cGMP biopharma process validation experience, including complex project management, required. Cross-functional team collaboration.
Anforderungen
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in process validation within a cGMP-regulated biopharmaceutical environment
- Proven experience in managing complex projects, ideally in MSAT or Quality
- Ability to manage multiple tasks and meet deadlines effectively
- Strong understanding of upstream and downstream processes, preferably in mammalian manufacturing
- Exposure to process development, scale-up, and/or manufacturing, preferably mammalian cell culture
- Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English (written and spoken); German is an advantage
- Able to come on site in Visp 60% of the time
Aufgaben
- Develop process validation strategies for assigned projects
- Prepare and author process validation protocols and reports
- Conduct supporting studies, including hold time and resin lifetime assessments
- Support Process Development teams during process characterization
- Maintain a detailed continued process verification plan
- Assess and approve Product Quality Reviews
- Review and approve process-related documents
- Evaluate process validation data against acceptance criteria
- Support investigations of deviations and approve deviation reports
- Act as a Subject Matter Expert for non-conformity records and change requests
- Represent Lonza in customer-facing meetings
- Assist in developing programs and Standard Operating Procedures to meet industry standards
- Act as process validation SME during inspections and audits
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CH12 Lonza AG 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.
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CHCH12 Lonza AG
Senior Process Validation Expert(m/w/x)
Visp
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing process validation strategies, authoring protocols, and conducting hold time/resin lifetime assessments at global biopharma leader. cGMP biopharma process validation experience, including complex project management, required. Cross-functional team collaboration.
Anforderungen
- Master’s or PhD degree in biotechnology, life sciences, or related disciplines
- Working experience in process validation within a cGMP-regulated biopharmaceutical environment
- Proven experience in managing complex projects, ideally in MSAT or Quality
- Ability to manage multiple tasks and meet deadlines effectively
- Strong understanding of upstream and downstream processes, preferably in mammalian manufacturing
- Exposure to process development, scale-up, and/or manufacturing, preferably mammalian cell culture
- Experience engaging with regulatory agencies (Swissmedic, FDA, etc.)
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English (written and spoken); German is an advantage
- Able to come on site in Visp 60% of the time
Aufgaben
- Develop process validation strategies for assigned projects
- Prepare and author process validation protocols and reports
- Conduct supporting studies, including hold time and resin lifetime assessments
- Support Process Development teams during process characterization
- Maintain a detailed continued process verification plan
- Assess and approve Product Quality Reviews
- Review and approve process-related documents
- Evaluate process validation data against acceptance criteria
- Support investigations of deviations and approve deviation reports
- Act as a Subject Matter Expert for non-conformity records and change requests
- Represent Lonza in customer-facing meetings
- Assist in developing programs and Standard Operating Procedures to meet industry standards
- Act as process validation SME during inspections and audits
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CH12 Lonza AG 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
CH12 Lonza AG
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Noch nicht perfekt?
- CH12 Lonza AG
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