3554 MSD AH Danube Biotech GmbH
Automatisierungs Ingenieur(m/w/x)
Vollzeitmit HomeofficeManagement
Krems an der Donau
ab 50.300 / Jahr
Neuer Job?Nejo!
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353554 MSD AH Danube Biotech GmbH
Validation and Qualification Engineer(m/w/x)
Krems an der Donau
ab 50.000 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Developing sterilization processes and qualifying production equipment for biopharmaceutical vaccines and immunotherapies. Experience in GMP production and equipment/process validation required. Collaboration across diverse teams.
Anforderungen
- Bachelor, Master or Engineering degree in Biotechnology, Process Engineering, (bio)chemistry, (micro)biology, or similar
- Ability to track qualification/requalification activities
- Adequate communication at all organizational levels
- Experience in GMP production company
- Experience in equipment qualification and process validation
- Strong knowledge and hands-on experience of (bio) process technology
- Strong knowledge and hands-on experience of microbiology
- Strong knowledge and hands-on experience of aseptic processing
- Strong knowledge and hands-on experience of equipment design
- Practical experience in risk management tools application
- Excellent communication and organizational capacity
- Experience in change management
- Ability to manage deviations and CAPAs
- Experience in continuous improvement tools and methodologies
- Very good knowledge of MS-Office applications
- Very good knowledge of German (verbal and written)
- Very good knowledge of English (verbal and written)
Aufgaben
- Lead qualification and validation activities
- Prepare qualification plans, protocols, and reports
- Develop procedures based on internal and external standards
- Plan and execute equipment and system qualifications with stakeholders
- Plan and execute cleaning and process validation with stakeholders
- Develop sterilization process cycles
- Qualify sterilization processes (thermal, chemical, physical)
- Re-qualify sterilization processes (thermal, chemical, physical)
- Participate in equipment, system, and process risk analysis
- Moderate equipment, system, and process risk analysis
- Perform Computerized Systems Validation (CSV) with IT and Process Automation
- Support improvement projects for qualification and validation
- Solve problems in qualification and validation activities
- Support change, deviation, and CAPA management
- Train staff in equipment qualification, risk assessments, and validation
- Ensure compliance with company safety guidelines
- Identify and address unsafe situations
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- Risk Management Tools
- Continuous Improvement Tools
- MS-Office
Benefits
Sonstige Zulagen
- Outstanding social benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 3554 MSD AH Danube Biotech GmbH 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?
- Merck & Co., Inc.
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353554 MSD AH Danube Biotech GmbH
Validation and Qualification Engineer(m/w/x)
Krems an der Donau
ab 50.000 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Developing sterilization processes and qualifying production equipment for biopharmaceutical vaccines and immunotherapies. Experience in GMP production and equipment/process validation required. Collaboration across diverse teams.
Anforderungen
- Bachelor, Master or Engineering degree in Biotechnology, Process Engineering, (bio)chemistry, (micro)biology, or similar
- Ability to track qualification/requalification activities
- Adequate communication at all organizational levels
- Experience in GMP production company
- Experience in equipment qualification and process validation
- Strong knowledge and hands-on experience of (bio) process technology
- Strong knowledge and hands-on experience of microbiology
- Strong knowledge and hands-on experience of aseptic processing
- Strong knowledge and hands-on experience of equipment design
- Practical experience in risk management tools application
- Excellent communication and organizational capacity
- Experience in change management
- Ability to manage deviations and CAPAs
- Experience in continuous improvement tools and methodologies
- Very good knowledge of MS-Office applications
- Very good knowledge of German (verbal and written)
- Very good knowledge of English (verbal and written)
Aufgaben
- Lead qualification and validation activities
- Prepare qualification plans, protocols, and reports
- Develop procedures based on internal and external standards
- Plan and execute equipment and system qualifications with stakeholders
- Plan and execute cleaning and process validation with stakeholders
- Develop sterilization process cycles
- Qualify sterilization processes (thermal, chemical, physical)
- Re-qualify sterilization processes (thermal, chemical, physical)
- Participate in equipment, system, and process risk analysis
- Moderate equipment, system, and process risk analysis
- Perform Computerized Systems Validation (CSV) with IT and Process Automation
- Support improvement projects for qualification and validation
- Solve problems in qualification and validation activities
- Support change, deviation, and CAPA management
- Train staff in equipment qualification, risk assessments, and validation
- Ensure compliance with company safety guidelines
- Identify and address unsafe situations
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- Risk Management Tools
- Continuous Improvement Tools
- MS-Office
Benefits
Sonstige Zulagen
- Outstanding social benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 3554 MSD AH Danube Biotech GmbH 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
3554 MSD AH Danube Biotech GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen agiert als weltweit zuverlässiger Hersteller und Lieferant von Biopharmazeutika und bietet innovative Impfstoffe und Immuntherapien an.
Noch nicht perfekt?
- 3554 MSD AH Danube Biotech GmbH
Automatisierungs Ingenieur(m/w/x)
Vollzeitmit HomeofficeManagementKrems an der Donauab 50.300 / Jahr - Merck & Co., Inc.
Specialist Production Support(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKrems an der Donauab 50.000 / Jahr - 3554 MSD AH Danube Biotech GmbH
Automatisierungstechniker(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKrems an der Donauab 50.300 / Jahr - MSD AH Danube Biotech GmbH
Reliability & Engineering Systems Lead(m/w/x)
Vollzeitmit HomeofficeSeniorKrems an der Donauab 67.600 / Jahr - globe personal services GmbH
Spezialist Automatisierungstechnik(m/w/x)
Vollzeitmit HomeofficeJuniorKrems an der Donauab 3.290 / Monat