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Jobs
Validation Engineer
North Carolina, US
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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