Validation Manager, CSV

2 days ago

College Station, Texas, United States FUJIFILM Corporation Full time
About This Role

FUJIFILM Diosynth Biotechnologies is a leading manufacturer of biotherapeutics and vaccines. We are seeking a highly skilled and experienced Validation Manager, CSV to join our team.

Key Responsibilities
  • Manage, schedule, and oversee all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle.
  • Ensure compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
  • Lead the development and approval of validation documentation, risk assessments, and impact assessments of proposed changes to computerized systems.
  • Supervise the activities of internal validation staff and external validation contractors.
  • Establish validation priorities to ensure deadlines are met.

Requirements

  • Master's Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Or Bachelor's Degree and 7+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Degree in Engineering or Science discipline is preferred.
  • 4+ years' experience in supervision of personnel.
  • Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.

Working with Us

FUJIFILM Diosynth Biotechnologies is a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

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