Project Coordinator Validation Services

1 week ago


Bengaluru, Karnataka, India Sartorius Full time

What you will accomplish together with us:

  • Understand customer requirements and concerns.
  • Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO).
  • Preparation of quotes for different test scenarios / scopes.
  • Customer visits and travel as and when necessary (e.g. acquiring new projects, presentation of Validation Services, generating validation leads) (less than 10%)
  • Ensure efficient and effective completion of validation projects under consideration of complexity and time in coordination with the sales team, the customer and the validation lab(s).
  • Preparation, review and approval (based on necessity) of scientific and technical validation documents (statements, protocols, reports and other documents) in English.
  • Track all validation leads and projects via applicable tools and provide monthly summary report.

What will convince us:

  • Masters degree or above in biotechnology, microbiology, chemistry or equivalent
  • Minimum 25 years experience in Validation Services, Filtration or life science industry.
  • Knowledge on microbiological aspects
  • Familiar with concept of GMP and GDP (Good Documentation Practices)
  • Knowledge on the concept of Extractables / Leachables and related analytical methods, e.g. HPLC-UV, GC-MS, LC-MS is a plus.
  • Understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements ( FDA, EMA, WHO etc.) is a plus.
  • Excellent interpersonal skills and ability to work in Global environment.


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