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SUSUSONITY

Process Validation Expert(m/w/x)

Aubonne
Full-timeOn-siteSenior

Process validation for NPI, TT, and process changes in Life Science and Healthcare. 5+ years biotech experience, including Drug Substance processes, required. 4-day work week, 6 weeks vacation.

Requirements

  • MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
  • At least 5 years of professional experience in biotechnology
  • Demonstrated experience in process validation
  • Strong experience in Drug Substance processes (asset)
  • Strong analytical capabilities
  • Strong synthesis capabilities
  • Excellent writing skills
  • Proficiency with GMP/GDP
  • Good knowledge of health authority requirements
  • Organization
  • Persistence
  • Resilience
  • Collaborative mindset
  • Ability to work well in a team
  • Ability to work independently and autonomously
  • Very good communication skills
  • Aptitude for digital tools
  • Interest in statistical analyses
  • Fluent French (spoken and written)
  • Fluent English (spoken and written)

Tasks

  • Define validation strategies for NPI, TT, and process changes
  • Identify risks and technical choices for project teams
  • Coordinate on-site process validation activities
  • Prepare required validation documents and plans
  • Train production teams on validation protocols
  • Supervise execution of validation protocols
  • Manage data and documentation using quality systems
  • Collect and compile production data
  • Interpret validation test results
  • Manage deviations and validation investigations
  • Update validation procedures and standards
  • Promote integrity and professional ethics
  • Ensure compliance with legal and regulatory directives

Work Experience

  • 5 years

Education

  • Master's degree

Languages

  • FrenchBusiness Fluent
  • EnglishBusiness Fluent

Benefits

Informal Culture

  • Culture of inclusion and belonging

Career Advancement

  • Opportunities for development and growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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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