Senior Validation Specialist

4 weeks ago


Omaha, Nebraska, United States Diverse Lynx Full time

Key Responsibilities:

As a Senior Validation Specialist at Diverse Lynx LLC, you will be responsible for ensuring compliance with 21 CFR part 11, ALCOA, and GxP regulations. You will have hands-on experience with MES Validation, FTPS, PMX, and a strong understanding of GDPR and SOX regulations.

Technical Requirements:

  • Knowledge of IO, OQ, and PQ testing
  • Experience with Agile framework and testing tools like Client ALM, JIRA, qTest, and VERAS
  • Understanding of Pharma concepts, CSV end-to-end lifecycle, and GAMP 5

Additional Requirements:

  • Awareness of HIPAA and SOX Compliance
  • Strong understanding of Traceability Matrix and Data Migration projects
  • Ability to author and review project deliverables

About Diverse Lynx LLC:

Diverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company. All qualified applicants will receive due consideration for employment without any discrimination.



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