Lead Validation Engineer

ValGenesis is a prominent digital validation platform provider for life sciences companies, being utilized by 30 of the top 50 global pharmaceutical and biotech companies. The suite of products offered by ValGenesis aids in achieving digital transformation, ensuring total compliance, and enhancing manufacturing excellence/intelligence throughout the product lifecycle. As the market leader in end-to-end digital validation, ValGenesis is seeking a Lead Validation Engineer to join the team in Chennai. In this role, you will be responsible for driving the validation processes of the innovative products to ensure they meet the highest quality standards. Your responsibilities will include collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities, reviewing Product Requirements, developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols, creating realistic test cases and datasets based on real-world customer scenarios, executing test cases, logging defects, documenting deviations, and reporting test outcomes. Additionally, you will be expected to peer review test documentation, work collaboratively in a dynamic team environment, understand and adhere to Quality Management System (QMS) standards, lead a team of engineers, manage product validation timelines, and ensure quality deliverables. To be successful in this role, you must possess a Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field, along with a minimum of 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment. Deep knowledge of the product development life cycle, understanding of GMP, FDA, and ISO regulations, proficiency with testing tools and Microsoft Office suite, self-motivation, excellent interpersonal, writing, communication, and troubleshooting skills, passion for testing, validation, and product quality, and the ability to mentor colleagues and lead small projects efficiently are essential requirements. ValGenesis is dedicated to pushing the boundaries of innovation in the life sciences industry, aiming to enhance and expand its portfolio beyond validation with an end-to-end digital transformation platform. The company is committed to achieving market leadership by combining purpose-built systems with world-class consulting services to meet evolving regulations and quality expectations in the GxP environment. Joining the ValGenesis team means being part of a culture that prioritizes customer success, fosters open communication, supports each other without reservation, values innovation, and is determined to become the number one intelligent validation platform in the market. The company believes in in-person interaction and collaboration, with offices in Chennai, Hyderabad, and Bangalore operating onsite five days a week to encourage creativity, community, and future success.,