Intellectt Inc

Validation Engineer

North Carolina, US

3 days ago
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Summary

Key Responsibilities:

  • Provide end-user support for LabVantage LIMS, including troubleshooting, issue resolution, and user training.
  • Create, verify, and manage master data and system configurations to meet laboratory operational requirements.
  • Collaborate with laboratory, IT, and QA teams to gather requirements, scope functionality, and implement LIMS changes.
  • Ensure system compliance with regulatory standards including 21 CFR Part 11, GMP, and internal SOPs.
  • Participate in system validation activities, including authoring and execution of test scripts (IQ/OQ/PQ).
  • Assist with change control, incident management, and periodic reviews for LIMS systems.
  • Support data integrity and documentation practices in alignment with regulatory expectations.
  • Facilitate continuous improvement by identifying opportunities to streamline or enhance system functionality.

Must-Have Qualifications:

  • Bachelor’s degree in Computer Science, Life Science, Applied Science, or a related field.
  • Proven experience with laboratory IT systems, including system installation, qualification, master data population, and configuration.
  • Hands-on experience with LabVantage LIMS in a regulated (GMP) laboratory environment.
  • Working knowledge of compliance and regulatory requirements in GMP settings.
  • Strong understanding of IT validation and system lifecycle documentation (URS, FS, DS, etc.).

Preferred Qualifications:

  • Master’s degree in Computer Science, Life Science, Applied Science, or a related discipline.
  • Familiarity with pharmaceutical or biotechnology industry standards.
  • Experience participating in audits and inspections related to laboratory systems.
  • Excellent communication skills, with the ability to interface effectively with both technical and non-technical stakeholders.

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