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QA Sterility Assurance Specialist(m/w/x)
Contamination control and risk assessments for aseptic processing in vaccine manufacturing. 5 years GMP biologics/sterile manufacturing, 2+ years QA aseptic leadership required. Direct impact on global health initiatives.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or related scientific field
- Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
- Strong background in sterility assurance or quality management within GMP-regulated environments
- Demonstrated experience in investigations, CAPA, risk management, and audit interactions
- Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
- Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
- Full professional proficiency in English; basic German is an advantage
- Proactive problem-solver with strong communication skills
Tasks
- Develop and maintain sterility assurance strategies
- Establish contamination control strategies for aseptic processing
- Lead risk assessments for aseptic processes and critical interventions
- Ensure compliance with relevant authorities' guidance
- Manage deviations and conduct root cause analyses for sterility issues
- Implement CAPA and efficiency checks for bioburden and endotoxin
- Provide training on aseptic and sterility best practices
- Mentor operations and QA staff to promote contamination control culture
- Stay updated on regulatory developments and revise procedures as needed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
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QA Sterility Assurance Specialist(m/w/x)
Contamination control and risk assessments for aseptic processing in vaccine manufacturing. 5 years GMP biologics/sterile manufacturing, 2+ years QA aseptic leadership required. Direct impact on global health initiatives.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or related scientific field
- Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
- Strong background in sterility assurance or quality management within GMP-regulated environments
- Demonstrated experience in investigations, CAPA, risk management, and audit interactions
- Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
- Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
- Full professional proficiency in English; basic German is an advantage
- Proactive problem-solver with strong communication skills
Tasks
- Develop and maintain sterility assurance strategies
- Establish contamination control strategies for aseptic processing
- Lead risk assessments for aseptic processes and critical interventions
- Ensure compliance with relevant authorities' guidance
- Manage deviations and conduct root cause analyses for sterility issues
- Implement CAPA and efficiency checks for bioburden and endotoxin
- Provide training on aseptic and sterility best practices
- Mentor operations and QA staff to promote contamination control culture
- Stay updated on regulatory developments and revise procedures as needed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Bavarian Nordic 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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