Validation Engineer

POSITION RESPONSIBILITIES:  Experience validating non product software (example- development, testing, mechanical) in healthcare domain ensuring compliance with FDA guidelines.  Conduct risk assessments to identify and prioritize validation activities.  Create and maintain essential validation documentation, including User Requirements Specifications (URS), Validation Plans, Test Protocols (IQ, OQ, PQ), and Final Validation Reports  Execute IQ, OQ, and PQ activities to ensure tools function as intended in the operational environment.  Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to align on validation strategies and ensure compliance  In-depth understanding of FDA guidance related to non-product software validation (e.g., 21 CFR Part 820) and familiarity with risk management principles and practices.  Familiarity with GAMP 5, Computer Software Assurance for Production and Quality System Software

DESIRED/PREFERRED QUALIFICATIONS:  Bachelor’s / master’s degree in computer science or equivalent.  Experience in software validation, in regulated environments with proven experience with tool validation processes.  Experience with Semiconductor manufacturing processes is preferred.  Strong analytical and problem-solving skills.  Excellent communication and documentation abilities.  Able to work in cross-functional and cross-cultural global teams  Knowledge of different software testing methodologies  Proficient in validation tools and methodologies.  Ability to work independently and collaboratively in a fast-paced environment.