Computer Systems Validation Associate Ii

Simtra BioPharma Solutions

Bloomington, United States
**
Computer systems validation
Validation document author/reviewer
Technical writing proficiency
** Simtra BioPharma Solutions is seeking a Computer Systems Validation Associate II to join their Technical Services team in Bloomington, Indiana. The role requires expertise in computer systems validation within a regulated environment, focusing on compliance and quality assurance. **

Job Summary

  • The Validation Associate II is a key member of the Computer Systems Validation team, responsible for ensuring computer systems meet worldwide regulatory agency requirements and industry best practices.
  • Key responsibilities include authoring and reviewing validation documents, coordinating user access reviews, managing change controls, and leading validation efforts for software implementations.
  • The company offers comprehensive benefits including medical, dental, 401(k) with company match, and various time-off programs, supporting employees in bringing life-changing medicines to patients.

Matching Summary

Match Score: 75

** Simtra BioPharma Solutions is seeking a Computer Systems Validation Associate II to join their Technical Services team in Bloomington, Indiana. The role requires expertise in computer systems validation within a regulated environment, focusing on compliance and quality assurance. **

Skills & Requirements

Must-have

  • computer systems validation
  • validation document author/reviewer
  • technical writing proficiency
  • GAMP Category 1 - 4
  • 21 CFR part 11 Gap analysis

Nice-to-have

  • collaborative approach
  • state of audit readiness
  • life-changing medicines

Key Requirements

  • 3+ years experience in regulated environment
  • Experience with enterprise software
  • Experience with Microsoft Project
  • Technical writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter