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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Bavarian Nordic Berna GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
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