Overview
On Site
Full Time
Skills
GxP
Attention To Detail
Test Scripts
IQ
OQ
PQ
Acceptance Testing
Traceability Matrix
Functional Requirements
Regulatory Compliance
MES
LIMS
Veeva
Manufacturing
Computerized System Validation
Test Cases
Root Cause Analysis
Corrective And Preventive Action
Defect Management
Collaboration
Quality Assurance
Manufacturing Operations
Auditing
Documentation
Computer Science
Testing
GMP
Pharmaceutics
Life Sciences
Job Details
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.
- 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).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.