Validation Engineer

4 weeks ago


Boston, Massachusetts, United States VASTEK GROUP INC Full time

This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs) client standards industry best practices and regulatory requirements.

The individual performs validation program-related activities such as DQ COM IQ OQ PQ CQ RQ etc.
Essential Duties and Responsibilities

  • Writes and executes commissioning qualification & validation protocols for facilities utilities equipment and computerized systems
  • Writes final reports
  • Resolves protocol discrepancies and deviations
  • Reviews vendor-generated validation protocol packages
  • Supports change control deliverables
  • Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practicesRequirements
  • Minimum of 0-1 year of experience.
  • BS/MS in Mechanical/Industrial/Manufacturing/Biology/Chemical/Biochemistry/Biomedical Engineering.


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