Validation Specialist

6 days ago


Boston, Massachusetts, United States Vastek, Inc. Full time
Job Summary

We are seeking a skilled Validation Specialist to join our team at Vastek, Inc.

About Us

Vastek, Inc. is a certified minority-owned small business company headquartered in San Diego with operations across the United States, Canada, Mexico, Italy, and India.

Job Description

This role involves supporting the Validation Manager in ensuring the effective implementation and maintenance of the Validation program.

  • Develop validation plans, qualification protocols, compile and analyze data, draft summary reports, and review validation documentation to ensure systems are qualified according to regulatory agencies, clients, and specifications.
  • Experience with equipment and/or computer system validation is highly valued.
  • Able to assess deviations that affect validation with minimal assistance.
  • Able to work on moderate Corrective Action Preventive Action (CAPA) resulting from deviations, internal audits, protocol discrepancies, global quality audits, or regulatory inspections.
  • Experience with autoclaves and VHP systems is an asset.
  • Able to speak as a Validation SME in audits.

The ideal candidate will have:

  • 2+ years of experience in validation.
  • Bachelor's degree required.
  • Computer system validation (CSV) experience.
  • GMP compliance expertise.
  • Previous experience with mechanical validation, CSV, change control, CAPAs/deviations, data integrity, and project management.

Estimated Salary Range: $70,000 - $90,000 per year



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