Senior Validation Engineer

Role Overview: You are invited to apply for the position of Senior Validation Engineer at ValGenesis. In this role, you will play a crucial part in ensuring the compliance and quality of the innovative software solutions designed for the life sciences industry. Your responsibilities will include collaborating with various teams to develop validation strategies, creating and executing test cases, and upholding project quality standards. Key Responsibilities: - Work independently to deliver results - Collaborate with Product, Engineering, and Testing teams to understand Product functions - Review various Product Requirements such as Epics, User stories, User Requirements, Software Requirements, etc. - Author test cases in OQ and PQ protocols following the requirements and QMS guidelines - Develop realistic test cases and test data based on customer usage scenarios - Conduct test case execution, defect creation, deviation creation, and report test results - Conduct peer reviews for Test cases, test data, and Test designs - Engage in a highly collaborative team environment with effective communication across team members - Demonstrate a good understanding of the company's QMS standards - Author documents in compliance with the QMS guidelines - Lead a team, provide continuous guidance, assign work, review outputs - Manage the Validation of a product, ensuring delivery quality and meeting timelines Qualification Required: - BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical, or a related field - Essential 5+ years of experience in Computer System Validation and Product Software Validation testing in a regulated environment - Sound knowledge of Product development life cycle - Understanding of GMP, FDA, and ISO regulations - Proficiency in testing tools and Microsoft Office products - Self-motivated individual with a willingness to quickly grasp new concepts, technologies, and products - Excellent interpersonal, writing, communication, and troubleshooting skills - Passionate about testing, Validation, and maintaining product quality - Ability to train and assist colleagues with less experience and lead small projects Additional Details: ValGenesis disrupted the life sciences industry in 2005 by introducing the world's first digital validation lifecycle management system. Their innovative solutions have set the industry standard and continue to evolve with an end-to-end digital transformation platform. ValGenesis emphasizes customer success, teamwork, innovation, and a commitment to becoming the top intelligent validation platform in the market. (Note: The additional details section has been included based on the information provided in the job description.),