GMP Tester / Validation Engineer Job at Katalyst CRO in Vacaville

Overview

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).

Job details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industries: Pharmaceutical Manufacturing

Location and additional job details are not included in this refined description.