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ValGenesis is a leading digital validation platform provider for life sciences companies, catering to 30 of the top 50 global pharmaceutical and biotech companies. ValGenesis plays a crucial role in enabling digital transformation, ensuring total compliance, and enhancing manufacturing excellence/intelligence throughout the product lifecycle. As a Senior Validation Engineer at ValGenesis, you will play a vital role in maintaining the compliance and quality of our innovative software solutions designed for the life sciences sector. Your responsibilities will include collaborating with various teams to develop comprehensive validation strategies, creating and executing test cases, and upholding the project's quality standards. Your responsibilities will involve hands-on work in an individual capacity to deliver results. You will work closely with Product, Engineering, and Testing teams to understand product functions. This will include reviewing various product requirements such as Epics, User stories, User Requirements, and Software Requirements. The creation of test cases in OQ and PQ protocols following QMS guidelines, as well as the generation of realistic test cases and test data based on customer usage scenarios, will be part of your tasks. Executing test cases, documenting defects and deviations, and reporting test results will also be essential. Peer reviewing test cases, test data, and test designs will be part of maintaining the project's quality standards. Moreover, you will be required to work in a highly collaborative team environment with effective communication across multiple team members. A good understanding of the company's QMS standards and authoring documents in accordance with QMS guidelines are key aspects of the role. You will also lead a team of individuals, providing guidance, allocating work, reviewing work, and managing the validation of a product to ensure delivery quality and timelines are met. To qualify for this position, you should hold a BE/BS degree or possess equivalent work experience in Computer Science, Biology, Biomedical, or a related field. A minimum of 5 years of experience in Computer System Validation and Product Software Validation testing in a regulated environment is essential. Knowledge of the Product development life cycle, GMP, FDA, and ISO regulations is required. Additionally, familiarity with testing tools, Microsoft Office products, and the ability to quickly learn new concepts, technologies, and products are crucial. Excellent interpersonal, writing, communication, and troubleshooting skills are necessary, along with a passion for testing, validation, and product quality. Lastly, you should be capable of training and assisting colleagues with less experience and leading small projects effectively. At ValGenesis, we are committed to innovation and continuous improvement. Our mission is to provide an end-to-end digital transformation platform that surpasses industry standards, ensuring compliance with evolving regulations and quality expectations. We prioritize customer success and collaboration within our team, fostering a culture of open communication and support. By thinking big and aiming for excellence, we are on a trajectory to become the top intelligent validation platform in the market, setting high standards for ourselves and our industry peers.,

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 excited to invite applications for the position of Senior Validation Engineer. In this role, you will be pivotal in ensuring the compliance and quality of our innovative software solutions tailored for the life sciences sector. As a Senior Validation Engineer, you will collaborate with diverse teams to develop comprehensive validation strategies, create and execute test cases, and maintain the project quality standard. Responsibilities - Hands on work at an individual capacity leading to deliverables - Diligently work with Product, Engineering and Testing teams to gain understanding of Product functions. - Review Product Requirements including Epics, User stories, User Requirements, Software Requirements etc. - Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines - Create realistic test cases and test data based on customer usage scenarios. - Execute test cases, create defects, create deviations, and report test results. - Peer review Test cases, test data and Test designs - Work in a highly collaborative team environment, with communication across many team members. - Good understanding of the company QMS standards - Author documents in accordance with the QMS guidelines - Lead of team of people Provide ongoing guidance, allocate work, review work - Manage the Validation of a product - be responsible for the delivery quality and timelines Requirements - BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical or related field. - Must-have 5+ years of Computer System Validation and Product Software Validation testing experience in a regulated environment. - Good knowledge of Product development life cycle - Understanding of GMP, FDA and ISO regulations - Good knowledge of testing tools and Microsoft office products - Self-motivated, willing to learn new concepts, technologies, and products quickly. - Excellent interpersonal, writing and communication skills, and troubleshooting skills. - Passionate about testing, Validation, and product quality - Able to train and help colleagues with less experience; be able to lead small projects. 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 foster creativity, a sense of community, and are critical to our future success as a company.,