CH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Vollzeitnur vor OrtJunior
Visp
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LOLonza
Process Validation Expert MSAT(m/w/x)
Visp
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Conducting performance qualification and continued verification for mammalian biopharma products. Minimum 1 year experience with cGMP biopharma process lifecycle management required. Work in a global life sciences setting.
Anforderungen
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven experience in managing complex projects
- Minimum 1 year of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Good understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Aufgaben
- Conduct process performance qualification activities
- Execute continued process verification tasks
- Plan, execute, and document validation protocols and reports
- Align validation activities with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Ensure project completion aligns with project management goals
- Collaborate with MSAT process experts and cross-functional teams
- Communicate critical process and technical information effectively
- Represent the company in customer meetings, audits, and inspections
- Provide technical expertise during audits and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop and implement standardized procedures for compliance
- Share information and knowledge across teams and functions
Berufserfahrung
- 1 Jahr
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 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
Process Validation Team Lead MSAT(m/w/x)
Vollzeitnur vor OrtManagementVisp - Lonza
Trainee MSAT Validation / MSAT Process Expert(m/w/x)
Vollzeitnur vor OrtKeine AngabeVisp - Lonza
Process Expert MSAT(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp
LOLonza
Process Validation Expert MSAT(m/w/x)
Visp
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Conducting performance qualification and continued verification for mammalian biopharma products. Minimum 1 year experience with cGMP biopharma process lifecycle management required. Work in a global life sciences setting.
Anforderungen
- Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
- Proven experience in managing complex projects
- Minimum 1 year of experience in process validation within a cGMP-regulated biopharmaceutical environment
- Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
- Good understanding of GMP
- Excellent communication, technical writing, and stakeholder management skills
- Fluency in English
Aufgaben
- Conduct process performance qualification activities
- Execute continued process verification tasks
- Plan, execute, and document validation protocols and reports
- Align validation activities with regulatory expectations (FDA, EMA, ICH)
- Manage technical risks associated with process validation
- Ensure project completion aligns with project management goals
- Collaborate with MSAT process experts and cross-functional teams
- Communicate critical process and technical information effectively
- Represent the company in customer meetings, audits, and inspections
- Provide technical expertise during audits and inspections
- Compile assessments of change requests and validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop and implement standardized procedures for compliance
- Share information and knowledge across teams and functions
Berufserfahrung
- 1 Jahr
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 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
MSAT Process Validation Specialist(m/w/x)
Vollzeitnur vor OrtJuniorVisp - CH12 Lonza AG
Process Validation Team Lead MSAT(m/w/x)
Vollzeitnur vor OrtManagementVisp - Lonza
Trainee MSAT Validation / MSAT Process Expert(m/w/x)
Vollzeitnur vor OrtKeine AngabeVisp - Lonza
Process Expert MSAT(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp