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MSAT Validation specialist

Engineering
Corsier-sur-Vevey
English

Who we are:Merck is a global leader in specialized pharma and chemicals, and for almost 350 years we have improved people?s quality of life. This is due to the creativity and team spirit of our 40,000 employees around the world; we are committed to help them develop and to reward their excellence. Merck makes great things happen.Your role:Within the MSAT (Manufacturing Sciences And Technology) Validation&Controls team located at Corsier-sur-Vevey (Vaud), your role will be:

  • To coordinate process and cleaning validation activities on our Drug Substance manufacturing process
  • To establish protocols and reports for defined process validation studies (Process Performance Qualification, impurities clearance, cumulative holding time, chromatography/membrane lifetime, process intermediates mixing, drug substance homogeneity, media & buffer mixing, media & buffer stability…) and cleaning validation studies (verification, validation and monitoring)
  • To develop validation strategies throughout the drug substance lifecycle (commercial submission, process/raw materials change…)
  • To ensure reliability and conformity of validation activities in line with internal and regulatory procedures and guidelines
  • To support Continued Process Verification activities for our commercial products
  • To liaise with relevant client departments to ensure validation activities are planned and executed in line with applicable deadline

Requirements:

Your profile:

  • Master in sciences (Biotechnology, Chemistry or Biology) with at least 3 years of experience in GMP environment
  • Experience in validation (process and/or cleaning)
  • Experience in project management and transverse coordination
  • Strong communication skills
  • Capability to collaborate and deliver in a matrix environment