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RORoche

Process Validation Engineer(m/w/x)

Basel
Full-timeOn-siteExperienced

Process validation for biopharmaceutical manufacturing, supporting tech transfers from development to commercial scale. GMP experience required. 4-person team, 5-day work week.

Requirements

  • University degree or equivalent training/experience in scientific/technical field
  • Preferably in biotechnology, bioprocess engineering, or (bio)chemical engineering
  • Experience in GMP environment
  • Ideally experience in planning/implementing process validation/characterization studies
  • Team player
  • Independent work in dynamic environment
  • Enjoy collaborating with diverse interfaces
  • Adaptability to rapidly changing environment
  • Flexibility in responding to requests
  • Very good intercultural communication skills
  • Very good communication skills
  • Bioprocess knowledge is a plus
  • Project management skills are a plus

Tasks

  • Develop process validation strategies
  • Execute process validation concepts
  • Support technology transfers from development to commercial scale
  • Own validation deliverables from concept to implementation
  • Create validation plans
  • Coordinate sample collection
  • Train team members on validation processes
  • Interpret validation results
  • Prepare validation reports
  • Plan troubleshooting activities
  • Collaborate with pilot laboratories
  • Coordinate with production and quality departments
  • Process deviations according to GMP guidelines
  • Manage changes in compliance with GMP
  • Support process optimization projects

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • GermanFluent
  • EnglishFluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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