Validation Engineer

As a Senior Validation Engineer at ValGenesis, you will play a crucial role in ensuring compliance and quality of the innovative software solutions tailored for the life sciences sector. Your responsibilities will include: - Working hands-on in an individual capacity to deliver project milestones. - Collaborating with Product, Engineering, and Testing teams to understand product functions. - Reviewing various product requirements such as Epics, User stories, and User Requirements. - Authoring test cases in OQ and PQ protocols in alignment with requirements and QMS guidelines. - Generating realistic test cases and test data based on customer usage scenarios. - Executing test cases, reporting test results, creating defects, and deviations. - Peer reviewing test cases, test data, and test designs. - Working in a highly collaborative team environment with effective communication. - Demonstrating a good understanding of the company's QMS standards. - Authoring documents in accordance with QMS guidelines. - Leading a team by providing ongoing guidance, allocating work, and reviewing work. - Managing the validation of a product, ensuring delivery quality and timelines. Requirements for this role include: - BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical, or related field. - Minimum of 5 years of experience in Computer System Validation and Product Software Validation testing in a regulated environment. - Knowledge of Product development life cycle, GMP, FDA, and ISO regulations. - Familiarity with testing tools and Microsoft Office products. - Self-motivated with a willingness to learn new concepts and technologies quickly. - Strong interpersonal, writing, communication, and troubleshooting skills. - Passion for testing, Validation, and product quality. - Ability to train and assist colleagues with less experience and lead small projects. ValGenesis disrupted the life sciences industry in 2005 with the introduction of the world's first digital validation lifecycle management system. Today, they continue to innovate, expanding their portfolio beyond validation with an end-to-end digital transformation platform. The company culture at ValGenesis is centered around customer success, teamwork, innovation, and a drive to be the number one intelligent validation platform in the market. The offices in Chennai, Hyderabad, and Bangalore operate onsite 5 days a week to foster creativity, collaboration, and community for future success.,