Bavarian Nordic Berna GmbH
Manufacturing Support Engineer(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSenior
Bern
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CSCSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for maintenance, utilities, and warehouse operations at global biotherapeutics developer for immunological therapies. 8+ years in similar role with engineering and maintenance operations expertise required. Autonomous work with critical quality projects in a global production setting.
Anforderungen
- 8+ years experience in similar role
- High independence and self-directed learning
- Knowledge of cGMP and Compliance
- Engineering and maintenance operations expertise
- Experience with utility monitoring programs
- Material management, warehousing, and logistics
- Quality control and analytical methods
- Change control management skills
- Deviation management skills
- CAPA management skills
- Strong collaboration and networking skills
- Coaching and mentoring skills
- Excellent communication and technical explanation
- Strong influencing and presentation skills
Aufgaben
- Provide quality oversight for maintenance and utilities
- Oversee quality control and warehouse operations
- Manage qualification activities for operational and re-qualification projects
- Ensure operational quality management follows cGMP standards
- Review and approve complex GxP documentation
- Support and approve quality risk assessments
- Manage non-conformances, investigations, and CAPAs
- Oversee complex change control processes
- Monitor quality performance metrics to drive improvements
- Lead complex cross-functional and global projects
- Act as Subject Matter Expert during inspections
- Collaborate with global quality assurance support functions
- Drive quality decisions with diverse internal stakeholders
- Conduct warehouse floor tours to address improvements
- Implement new Quality on the Floor activities
- Manage complex deviations at local and cross-site levels
- Serve as Quality Delegate for change management
- Review and complete raw material data for APR/PQR
- Lead cross-functional Tier 1 operational meetings
- Coordinate and deliver GMP training for new employees
- Present quality investigations to health authorities
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- Utility monitoring programs
- Change control management
- Deviation management
- CAPA management
Benefits
Sonstige Vorteile
- Reasonable accommodation for disabilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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?
- Bavarian Nordic Berna GmbH
Quality Assurance Specialist Qualification(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern - Bavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Scientific Expert Quality Assurance 100%(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern - CSL Behring
Subject Matter Expert Quality Support(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern
CSCSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for maintenance, utilities, and warehouse operations at global biotherapeutics developer for immunological therapies. 8+ years in similar role with engineering and maintenance operations expertise required. Autonomous work with critical quality projects in a global production setting.
Anforderungen
- 8+ years experience in similar role
- High independence and self-directed learning
- Knowledge of cGMP and Compliance
- Engineering and maintenance operations expertise
- Experience with utility monitoring programs
- Material management, warehousing, and logistics
- Quality control and analytical methods
- Change control management skills
- Deviation management skills
- CAPA management skills
- Strong collaboration and networking skills
- Coaching and mentoring skills
- Excellent communication and technical explanation
- Strong influencing and presentation skills
Aufgaben
- Provide quality oversight for maintenance and utilities
- Oversee quality control and warehouse operations
- Manage qualification activities for operational and re-qualification projects
- Ensure operational quality management follows cGMP standards
- Review and approve complex GxP documentation
- Support and approve quality risk assessments
- Manage non-conformances, investigations, and CAPAs
- Oversee complex change control processes
- Monitor quality performance metrics to drive improvements
- Lead complex cross-functional and global projects
- Act as Subject Matter Expert during inspections
- Collaborate with global quality assurance support functions
- Drive quality decisions with diverse internal stakeholders
- Conduct warehouse floor tours to address improvements
- Implement new Quality on the Floor activities
- Manage complex deviations at local and cross-site levels
- Serve as Quality Delegate for change management
- Review and complete raw material data for APR/PQR
- Lead cross-functional Tier 1 operational meetings
- Coordinate and deliver GMP training for new employees
- Present quality investigations to health authorities
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- Utility monitoring programs
- Change control management
- Deviation management
- CAPA management
Benefits
Sonstige Vorteile
- Reasonable accommodation for disabilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
- Bavarian Nordic Berna GmbH
Manufacturing Support Engineer(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorBern - Bavarian Nordic Berna GmbH
Quality Assurance Specialist Qualification(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern - Bavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Scientific Expert Quality Assurance 100%(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern - CSL Behring
Subject Matter Expert Quality Support(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern