Computer Systems Validation Associate Ii

Simtra BioPharma Solutions

Bloomington, United States
On-site
Computer systems validation (csv)
Cgmp manufacturing environment
Technical writing proficiency
Simtra BioPharma Solutions is seeking a Computer Systems Validation Associate II in Bloomington, Indiana. The role involves leading validation efforts related to computer systems, ensuring compliance with regulatory standards, and contributing to quality assurance in the pharmaceutical and biotech industry

Job Summary

  • The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization, acting as the lead validation resource.
  • Responsibilities include authoring/reviewing validation documents, coordinating user access reviews, owning change controls, and leading CSV for software implementations.
  • The role requires a BS degree (preferred), 3+ years of experience in a regulated environment, and proficiency with enterprise software and Microsoft Project.

Matching Summary

Match Score: 85

Simtra BioPharma Solutions is seeking a Computer Systems Validation Associate II in Bloomington, Indiana. The role involves leading validation efforts related to computer systems, ensuring compliance with regulatory standards, and contributing to quality assurance in the pharmaceutical and biotech industry.

Skills & Requirements

Must-have

  • Computer Systems Validation (CSV)
  • cGMP manufacturing environment
  • Technical writing proficiency
  • Risk assessment and 21 CFR part 11 Gap analysis
  • Global Change Control task owner

Nice-to-have

  • Collaborative approach
  • Life-changing medicines
  • State of audit readiness

Key Requirements

  • 3+ years experience in regulated environment
  • BS in Electronic or Software Engineering, Information Systems, or related field, preferred
  • Experience with enterprise software (ERP, EDMS, QMS, JDE, Trackwise)
  • Experience with Microsoft Project
  • Technical writing skills

Work Rights

Not specified

Tailored Resume

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