Computerized System Validation Expert

7 days ago


Arthur, Illinois, United States Lynkx Staffing LLC Full time
Job Description

We are seeking a highly experienced Computerized System Validation Expert to join our team at Lynkx Staffing LLC. This role is responsible for ensuring the quality and integrity of computerized systems, adhering to regulatory requirements such as 21 CFR Part 11, GAMP5, and EU Annex 11.

Key Responsibilities:
  • Validation Strategies: Develop and execute validation strategies for new and existing computerized systems, ensuring compliance with company standards and regulatory requirements.
  • Regulatory Compliance: Ensure all computerized system activities adhere to FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10, and industry best practices.
  • Team Collaboration: Collaborate with IT and system owners to implement new computerized systems, upgrades, or modifications, ensuring compliance with regulatory requirements.
Requirements:
  • Bachelor's Degree: Scientific or Engineering discipline
  • Experience: 8+ years of computerized system experience with IT compliance/validation/qualification activities; 8+ years in an FDA-regulated, GxP-related environment
  • Skills: Demonstrated expertise in 21 CFR Part 11, comprehensive knowledge in Software Validation and Data Integrity Principles, and experience with LIMS system implementations
Estimated Salary: $130,000 - $160,000 per annum

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