Skip to content
New Job?Nejo!

Your personal AI career agent

BABavarian Nordic Berna GmbH

Validation Engineer in MSAT(m/w/x)

Bern
Full-timeWith Home OfficeExperienced

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

  • GermanBusiness Fluent
  • EnglishBusiness Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic Berna GmbH 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.

  • Bavarian Nordic Berna GmbH

    MSAT Trainee(m/w/x)

    Full-timeTemporary contractWith HomeofficeJunior
    Bern
  • Bavarian Nordic Berna GmbH

    Senior QA Manager, QV & CSV(m/w/x)

    Full-timeWith HomeofficeManagement
    Bern
  • Bavarian Nordic GmbH

    Scientist QC for Stability Programs(m/w/x)

    Full-timeWith HomeofficeSenior
    Bern
  • Bavarian Nordic GmbH

    Site ERP Deployment Lead, Production and Supply Chain(m/w/x)

    Full-timeWith HomeofficeSenior
    Bern
  • Bavarian Nordic GmbH

    Demand and Supply Planner(m/w/x)

    Full-timeWith HomeofficeSenior
    Bern
View all 100+ similar jobs

Nejo is an AI – results may be incomplete or contain mistakes