Bavarian Nordic Berna GmbH
Manufacturing Support Engineer(m/w/x)
Full-timeTemporary contractOn-siteSenior
Bern
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CSCSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- Utility monitoring programs
- Change control management
- Deviation management
- CAPA management
Benefits
Other Benefits
- Reasonable accommodation for disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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CSCSL Behring
Associate Director, Quality Assurance Support(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- cGMP
- Utility monitoring programs
- Change control management
- Deviation management
- CAPA management
Benefits
Other Benefits
- Reasonable accommodation for disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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