Lonza
Process Validation Expert MSAT(m/w/x)
Vollzeitnur vor OrtJunior
Visp
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CHCH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Visp
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Performance qualification and continued verification for biopharmaceutical manufacturing in Mammalian Manufacturing at a global life sciences firm. Minimum 1 year in cGMP-regulated biopharmaceutical validation activities required. Global project scope, exposure to diverse regulatory frameworks.
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 process validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop validation lifecycle strategies
- Implement standardized procedures for compliance across the network
- Share knowledge and information 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 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
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
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Process Expert MSAT(m/w/x)
Vollzeitnur vor OrtSeniorVisp
CHCH12 Lonza AG
MSAT Process Validation Specialist(m/w/x)
Visp
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Performance qualification and continued verification for biopharmaceutical manufacturing in Mammalian Manufacturing at a global life sciences firm. Minimum 1 year in cGMP-regulated biopharmaceutical validation activities required. Global project scope, exposure to diverse regulatory frameworks.
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 process validation deviations
- Review CMC sections in filing documents and validation reports
- Participate in continuous improvement initiatives
- Develop validation lifecycle strategies
- Implement standardized procedures for compliance across the network
- Share knowledge and information 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 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?
- Lonza
Process Validation Expert MSAT(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
MSAT Process Expert Mammalian Upstream Large-Scale(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Process Expert MSAT(m/w/x)
Vollzeitnur vor OrtSeniorVisp