Validation Engineering
United Pharma
Responsibilities
Manage qualification and lifecycle activities for QC laboratory instruments and software systems
Author and execute URS, DQ, IQ/OQ protocols, validation plans, risk assessments, and summary reports
Perform Computer System Validation (CSV) activities and software testing
Support change controls, deviations, investigations, and CAPA implementation
Maintain asset management records, calibration schedules, and preventive maintenance activities
Coordinate with vendors for installation, qualification, and troubleshooting activities
Qualifications
Bachelor's or Master\'s degree in Engineering, Biology, Chemistry, or related field
2–4+ years of Validation, CSV, or laboratory systems experience in a GMP environment
Strong knowledge of cGMP, 21 CFR Part 11, GAMP, Data Integrity, and Electronic Records requirements
Experience with change controls, deviations, investigations, and quality systems
Familiarity with laboratory instruments, computerized systems, and validation documentation
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