Senior Validation Engineer

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.,