Computer Validation Specialist
Morristown, New Jersey | contract
Our client in Morristown, NJ has a contract opening for a Computer Validation Specialist.
- Lead planning, creation, review, and execution of GxP documentation deliverables (plans, protocols, tests, reports, etc.).
- Ensure GxP document deliverables are in compliance with Site and Corporate policies and procedures following a Risk-based Lifecycle Approach from URS development through system retirement.
- Maintain System Validation, Data Integrity, CFR 21 Part 11 Compliance, in Change Management Process
- Work closely with business stakeholders, technical support groups, and QA to thoroughly investigate validation discrepancies and drive best-practice for systems validation;
- Bachelor's Degree in Computer Science, Life or Physical Sciences, or related discipline.
- 5-10 years of experience in a GXP environment or validation of IT applications, or an equivalent combination of education and experience.
- Knowledge of GXP and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and Change Management Processes
- Experience in the implementation and validation of stand-alone IT applications as well as complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems.
- Technical proficiency, attention to detail, creativity, innovation, and independent thought.
Computer Validation Specialist - 15490