Description

You will manage end-to-end validation documentation and testing for a TrakSys MES upgrade project.

Responsibilities

• Develop complete validation documentation packages including requirements, validation plans, test protocols, and traceability matrices.
• Execute dry-run testing and compile validation summary reports.
• Validate custom, embedded, and firmware-based applications to ensure compliance.
• Collaborate with project stakeholders and engineering teams to align on validation goals.

Required Skills

• 5+ years of experience in computer systems validation (CSV) within GMP/GxP regulated environments.
• Experience validating Manufacturing Execution Systems (MES), specifically Traksys.
• Proficiency in writing SQL queries for MS SQL, MySQL, or Oracle relational databases.
• Practical application of GAMP5 validation models and FDA 21 CFR Part 11 requirements.
• Expertise using Jira for test case writing, issue tracking, and version release.
• Strong understanding of risk-based validation approaches and medical device regulations.
• Knowledge of SDLC, Waterfall, and Agile software development methodologies.
• Bachelor's degree or equivalent graduate level education.

Preferred Skills

• Experience with test automation suites and framework development.
• Direct experience working within a medical device manufacturing facility.

Key Skills

Education

Any Gradute