GMP Tester / Validation Engineer
GMP Tester / Validation Engineer
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Salary Not Disclosed
1 Vacancy
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.
- 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.
- Bachelors or masters 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).
Employment Type
Full-time
