Principal Consultant – CSV Analyst

We are looking for a Principal Consultant – CSV Analyst to prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. In this role, you will assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met.

Requirements

• Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
• Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release
• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
• Execution of validation plans and validation documents

Benefits

• Competitive salary and benefits package
• Opportunities for career growth and professional development
• Collaborative and dynamic work environment
• Comprehensive health insurance
• Retirement plan
• Generous paid time off