Dein persönlicher KI-Karriere-Agent
Validation Engineer in MSAT(m/w/x)
Process, cleaning, and shipping validation for life-saving vaccines. Experience with mid/large-scale validation in GMP Life Science preferred. High autonomy, German and English communication skills required.
Anforderungen
- Bachelor's degree or higher in Life Sciences
- High autonomy and initiative
- Excellent written (technical writing) and verbal communication in German and English
- Experience with mid/large-scale process/cleaning validation in GMP Life Science (Biotech preferred) is a plus
- Cell culture, downstream processing, aseptic manufacturing experience is a plus
Aufgaben
- Plan and execute process, cleaning, and shipping validation
- Support Process Performance Qualification (PPQ) campaigns
- Lead technical investigations and support Manufacturing Support Engineers
- Ensure continued process verification
- Collect and analyze validation data
- Identify trends and troubleshoot issues
- Improve processes and prepare validation reports
- Author and lead process risk analysis
- Define process control strategy
- Represent as Validation Subject Matter Expert (SME) on global project teams
- Represent as Validation SME on internal teams
- Author and support deviations and investigations
- Manage change controls in manufacturing
- Recommend and implement process changes
- Perform process monitoring and statistical analysis
- Author continued process verification reports (CPV)
- Provide data and analyses for annual Product Quality Reviews (PQR)
- Participate in internal, customer, and regulatory inspections
- Support Technology Transfer projects
- Drive Operational Excellence and Environmental Health and Safety improvements
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- Bavarian Nordic Berna GmbHVollzeitBefristeter Vertragmit HomeofficeJuniorBern
- Bavarian Nordic Berna GmbH
Senior QA Manager, QV & CSV(m/w/x)
Vollzeitmit HomeofficeManagementBern - Bavarian Nordic GmbH
Scientist QC for Stability Programs(m/w/x)
Vollzeitmit HomeofficeSeniorBern - Bavarian Nordic GmbH
Site ERP Deployment Lead, Production and Supply Chain(m/w/x)
Vollzeitmit HomeofficeSeniorBern - Bavarian Nordic GmbH
Demand and Supply Planner(m/w/x)
Vollzeitmit HomeofficeSeniorBern
Validation Engineer in MSAT(m/w/x)
Process, cleaning, and shipping validation for life-saving vaccines. Experience with mid/large-scale validation in GMP Life Science preferred. High autonomy, German and English communication skills required.
Anforderungen
- Bachelor's degree or higher in Life Sciences
- High autonomy and initiative
- Excellent written (technical writing) and verbal communication in German and English
- Experience with mid/large-scale process/cleaning validation in GMP Life Science (Biotech preferred) is a plus
- Cell culture, downstream processing, aseptic manufacturing experience is a plus
Aufgaben
- Plan and execute process, cleaning, and shipping validation
- Support Process Performance Qualification (PPQ) campaigns
- Lead technical investigations and support Manufacturing Support Engineers
- Ensure continued process verification
- Collect and analyze validation data
- Identify trends and troubleshoot issues
- Improve processes and prepare validation reports
- Author and lead process risk analysis
- Define process control strategy
- Represent as Validation Subject Matter Expert (SME) on global project teams
- Represent as Validation SME on internal teams
- Author and support deviations and investigations
- Manage change controls in manufacturing
- Recommend and implement process changes
- Perform process monitoring and statistical analysis
- Author continued process verification reports (CPV)
- Provide data and analyses for annual Product Quality Reviews (PQR)
- Participate in internal, customer, and regulatory inspections
- Support Technology Transfer projects
- Drive Operational Excellence and Environmental Health and Safety improvements
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Bavarian Nordic Berna GmbH
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
Noch nicht perfekt?
- Bavarian Nordic Berna GmbH
MSAT Trainee(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeJuniorBern - Bavarian Nordic Berna GmbH
Senior QA Manager, QV & CSV(m/w/x)
Vollzeitmit HomeofficeManagementBern - Bavarian Nordic GmbH
Scientist QC for Stability Programs(m/w/x)
Vollzeitmit HomeofficeSeniorBern - Bavarian Nordic GmbH
Site ERP Deployment Lead, Production and Supply Chain(m/w/x)
Vollzeitmit HomeofficeSeniorBern - Bavarian Nordic GmbH
Demand and Supply Planner(m/w/x)
Vollzeitmit HomeofficeSeniorBern