Lead Computer Systems Validation Engineer

2 weeks ago


South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time
Position: Senior Validation Engineer

Company: Katalyst HealthCares & Life Sciences

Key Responsibilities:
  • Engage in various roles across systems including SDMS, Labx, Veeva RIM, ValGenesis, and Labware LIMS.
  • Conduct thorough risk evaluations concerning Data Integrity.
  • Analyze deviations and implement corrective actions within CGMP environments.
  • Perform compliance assessments related to Data Integrity and generate comprehensive executive summary reports.
  • Work collaboratively with both internal and external stakeholders to evaluate the maturity state of Data Integrity.
  • Possess a strong understanding of GMP standards and current quality trends.
  • Demonstrate the ability to independently resolve issues and complete system qualifications within specified constraints.
  • Exhibit expertise in system qualification, application validation, and adherence to regulatory standards.
  • Hold a Bachelor’s degree in a scientific or engineering field, complemented by relevant experience.
  • Have a background in pharmaceutical application systems that support laboratory and production operations.
  • Possess experience in validation protocols for computer systems.
  • Ability to create various system life cycle deliverables and validation protocols.
  • Demonstrate proficiency in MS Office applications.


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