GMP Tester / Validation Engineer

Job Description:

We are seeking a skilled GMP Tester / Validation Engineer with strong experience in testing and validating applications in regulated environments (GMP, GxP, Pharma, Life Sciences).
The ideal candidate will have hands-on expertise in validation testing, documentation, and compliance for critical applications such as MES, LIMS, ArchestrA, and manufacturing systems.
This role requires a detail-oriented professional who can design and execute validation tests, review traceability matrices, ensure regulatory compliance, and collaborate with cross-functional teams in a pharmaceutical manufacturing environment.

Responsibilities:

Design, develop, and execute validation test scripts (IQ, OQ, PQ, UAT) for GMP-regulated applications.
Perform traceability matrix review to ensure all functional requirements are covered and validated.
Conduct validation and compliance testing for pharma applications (MES, LIMS, ArchestrA, DCS, Veeva, InBatch, etc.).
Assess system interactions across development, validation, and production environments.
Ensure adherence to Good Manufacturing Practices (GMP) and Computer System Validation (CSV) guidelines.
Document test cases, test results, and deviations as per regulatory requirements.
Perform root cause analysis of failures and implement corrective and preventive actions (CAPA).
Support defect management, bug fixes, and enhancements in validated environments.
Collaborate with cross-functional teams including QA, IT, and manufacturing operations.
Provide support during audits and inspections by ensuring complete and compliant validation documentation.

Requirements:

Bachelor's or master's degree in computer science, Engineering, Life Sciences, or related field.
5+ years of experience in validation testing in GMP-regulated environments (Pharma, Biotech, Life Sciences).