Lonza
Process Validation Expert MSAT(m/w/x)
Vollzeitnur vor OrtJunior
Visp
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CHCH12 Lonza AG
Process Validation Team Lead MSAT(m/w/x)
Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Ensuring consistent quality in mammalian biopharmaceutical manufacturing processes, overseeing protocols and regulatory compliance. 5+ years ensuring cGMP biopharma process quality with proven leadership experience required. Global project scope, supportive team environment.
Anforderungen
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven leadership experience in managing technical teams and complex projects
- Minimum 5 years of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Strong understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Aufgaben
- Lead and manage the process validation team
- Create a supportive and growth-oriented team environment
- Oversee resource allocation, goal setting, and performance evaluations
- Plan, execute, and document validation protocols and reports
- Ensure compliance with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Collaborate with MSAT leaders and cross-functional teams
- Communicate critical process and technical information
- Oversee validation data for protocol acceptance criteria
- Conduct statistical analysis for CPV reporting
- Represent the company in customer meetings, audits, and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Drive continuous improvement initiatives
- Support the development of standardized procedures for compliance
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
Noch nicht perfekt?
- CH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Vollzeitnur vor OrtJuniorVisp - Lonza
Team Lead - Mammalian Process Development Downstream(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Head Manufacturing Science and Technology(m/w/x)
Vollzeitnur vor OrtSeniorVisp
CHCH12 Lonza AG
Process Validation Team Lead MSAT(m/w/x)
Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Ensuring consistent quality in mammalian biopharmaceutical manufacturing processes, overseeing protocols and regulatory compliance. 5+ years ensuring cGMP biopharma process quality with proven leadership experience required. Global project scope, supportive team environment.
Anforderungen
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven leadership experience in managing technical teams and complex projects
- Minimum 5 years of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Strong understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Aufgaben
- Lead and manage the process validation team
- Create a supportive and growth-oriented team environment
- Oversee resource allocation, goal setting, and performance evaluations
- Plan, execute, and document validation protocols and reports
- Ensure compliance with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Collaborate with MSAT leaders and cross-functional teams
- Communicate critical process and technical information
- Oversee validation data for protocol acceptance criteria
- Conduct statistical analysis for CPV reporting
- Represent the company in customer meetings, audits, and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Drive continuous improvement initiatives
- Support the development of standardized procedures for compliance
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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
Healthcare
Beschreibung
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Noch nicht perfekt?
- Lonza
Process Validation Expert MSAT(m/w/x)
Vollzeitnur vor OrtJuniorVisp - CH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Vollzeitnur vor OrtJuniorVisp - Lonza
Team Lead - Mammalian Process Development Downstream(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Head Manufacturing Science and Technology(m/w/x)
Vollzeitnur vor OrtSeniorVisp