Job Description

Key Responsibilities:

Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures. Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations. Support and coordinate validation testing activities under QA oversight. Ensure all documentation and test evidence meet data integrity (ALCOA+) and GxP compliance requirements. Participate in defect tracking, test incident resolution, and retest documentation. Collaborate with QA validation teams during review and approval of CSV deliverables. Contribute to change control, periodic review, and system revalidation activities. Maintain accurate audit-ready documentation for all validation activities.

Qualifications and Requirements:

Bachelors degree in Engineering, Computer Science, Life Sciences, or related discipline. 3-6 years of experience in Computer System Validation within GxP-regulated environments. Proven experience in test case drafting, execution, and validation reporting. Exposure to validation of systems such as MES, LIMS, DCS/PLC, ERP, or other computerized systems. Sound understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles. Strong documentation and analytical skills. Ability to work collaboratively with QA, IT, and Engineering functions.
Job Types: Full-time, Contract
Contract length: 24 months

Pay: $6,000.00 - $8,000.00 per month

Benefits:

Health insurance
Work Location: In person