Lead Validation Engineer

Job Description

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards. Responsibilities Collaborating with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities. Reviewing Product Requirements including Epics, User Stories, and Software Requirements. Developing thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols aligned with guidelines. Creating realistic test cases and datasets based on real-world customer scenarios. Executing test cases, logging defects, documenting deviations, and reporting test outcomes. Peer reviewing test documentation to ensure quality and adherence to standards. Working collaboratively in a dynamic team environment with open communication. Understanding and adhering to Quality Management System (QMS) standards. Leading a team of engineers, providing guidance, overseeing workload, and conducting reviews. Managing product validation timelines and ensuring quality deliverables. Requirements Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field. At least 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-motivated with a willingness to quickly learn new technologies and products. Excellent interpersonal, writing, communication, and troubleshooting skills. Passionate about testing, validation, and product quality. Able to mentor colleagues and lead small projects efficiently. We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.