Validation Engineer III

5 days ago


College Station, Texas, United States FUJIFILM Corporation Full time
Job Title: Validation Engineer III

FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a highly skilled Validation Engineer III to join our team. As a key member of our validation team, you will be responsible for planning and organizing validation activities across cross-functional groups, generating and executing validation deliverables, and ensuring compliance with regulatory and procedural requirements.

Key Responsibilities:
  • Develop and execute validation protocols, deviations, and validation summary reports
  • Utilize Validation Life Cycle Concept and apply single-use technology
  • Employ GMP, GDP, GLP practices and guidelines, including 21CFR Part11 & Part210, 50, 56, 58, EU Annex 11, ICH (IND, NDA), USP, ASME, and ISPE
  • Review FUSE System Delivery Life Cycle (SDLC) deliverables and ensure adherence to Standard Operating Procedures (SOPs)
  • Update SOPs, forms, templates, documentation, and files
Requirements:
  • Bachelor's Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field
  • Five (5) years of experience in a validation role, including five (5) years of validation experience in a pharmaceutical, biotechnology, or related industry
  • OR Master's Degree in Information Systems Security, Biotechnology, Pharmaceutical Science, or related field and two (2) years of experience in a validation role
Salary:

$109,000 - $115,000

How to Apply:

Please apply directly at [insert link]



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