Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Stein (AR)
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
LOLonza
MSAT Expert Drug Product(m/w/x)
Stein (AR)
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Supporting commercial readiness for large-scale aseptic fill&finish facilities and capital investment projects. Significant aseptic/sterile fill&finish experience in GMP required. Relocation assistance, agile career path.
Anforderungen
- University degree or equivalent technical education in Biotechnology, Pharmacy, or related field
- Significant experience in aseptic/sterile fill&finish processes of drug products in GMP environment
- Substantial know-how in aseptic processing and sterility assurance principles
- Experience in qualification of manufacturing equipment
- Experience in cleaning validation
- Experience in room qualification
- Strong communication skills
- Ability to translate complex technical topics into clear actionable messages
- Proactive, positive approach
- Problem-solving attitude
- Ability to take full responsibility for assigned areas
- Ability to lead cross-functional teams
- Ability to drive decision-making in a matrix organization
- Ability to build strong networks and trust across internal and external stakeholders
- Proficiency in English
- German language skills
Aufgaben
- Support commercial readiness for large-scale aseptic fill&finish facility
- Act as MSAT Expert in capital investment projects
- Build and commission manufacturing units
- Ensure commercial readiness for GMP manufacturing facility
- Define qualification strategies for DP manufacturing equipment
- Align qualification concepts with regulatory requirements
- Lead cross-functional project teams
- Provide technical leadership in sterile manufacturing process design
- Design cleanroom layout, material/personnel flow, and equipment placement
- Craft Aseptic Process Simulation concept
- Align APS with internal guidelines and regulatory requirements
- Provide oversight during APS execution
- Support technical investigations of aseptic manufacturing process
- Develop aseptic technique training programs
- Lead risk assessments (e.g., FMEA)
- Identify critical manufacturing process parameters
- Develop control strategies for the facility
- Author and review GMP documents
- Create Qualification/Validation master plans, protocols, and reports
- Develop SOPs and manufacturing concepts
- Ensure GMP documentation readiness for authority inspections
- Contribute to standardized MSAT procedures
- Implement qualification standards
- Develop single-use systems and filtration systems
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Startup-Atmosphäre
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
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 Expert - sterile filling of biopharmaceutical Drug Product(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Process Expert - prefilled Syringes(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Plant Engineer aseptic Fill and Finish DPS Growth Project(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR)
LOLonza
MSAT Expert Drug Product(m/w/x)
Stein (AR)
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Supporting commercial readiness for large-scale aseptic fill&finish facilities and capital investment projects. Significant aseptic/sterile fill&finish experience in GMP required. Relocation assistance, agile career path.
Anforderungen
- University degree or equivalent technical education in Biotechnology, Pharmacy, or related field
- Significant experience in aseptic/sterile fill&finish processes of drug products in GMP environment
- Substantial know-how in aseptic processing and sterility assurance principles
- Experience in qualification of manufacturing equipment
- Experience in cleaning validation
- Experience in room qualification
- Strong communication skills
- Ability to translate complex technical topics into clear actionable messages
- Proactive, positive approach
- Problem-solving attitude
- Ability to take full responsibility for assigned areas
- Ability to lead cross-functional teams
- Ability to drive decision-making in a matrix organization
- Ability to build strong networks and trust across internal and external stakeholders
- Proficiency in English
- German language skills
Aufgaben
- Support commercial readiness for large-scale aseptic fill&finish facility
- Act as MSAT Expert in capital investment projects
- Build and commission manufacturing units
- Ensure commercial readiness for GMP manufacturing facility
- Define qualification strategies for DP manufacturing equipment
- Align qualification concepts with regulatory requirements
- Lead cross-functional project teams
- Provide technical leadership in sterile manufacturing process design
- Design cleanroom layout, material/personnel flow, and equipment placement
- Craft Aseptic Process Simulation concept
- Align APS with internal guidelines and regulatory requirements
- Provide oversight during APS execution
- Support technical investigations of aseptic manufacturing process
- Develop aseptic technique training programs
- Lead risk assessments (e.g., FMEA)
- Identify critical manufacturing process parameters
- Develop control strategies for the facility
- Author and review GMP documents
- Create Qualification/Validation master plans, protocols, and reports
- Develop SOPs and manufacturing concepts
- Ensure GMP documentation readiness for authority inspections
- Contribute to standardized MSAT procedures
- Implement qualification standards
- Develop single-use systems and filtration systems
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Startup-Atmosphäre
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
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?
- Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - CH12 Lonza AG
Process Expert - sterile filling of biopharmaceutical Drug Product(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Process Expert - prefilled Syringes(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Plant Engineer aseptic Fill and Finish DPS Growth Project(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR)