Validation Engineer
7 days ago
ValGenesis is looking for a proactive Validation Engineer to join their team. As a Validation Engineer, you'll ensure that the software products meet quality standards and comply with regulations. You'll collaborate with various teams to validate software systems, conduct risk assessments, and create validation documentation.
Responsibilities
- Engage in hands-on work independently to meet objectives
- Collaborate with Product, Engineering, and Testing teams to understand Product functions
- Review Product Requirements like Epics, User stories, Software Requirements
- Create test cases in OQ and PQ protocols, following QMS guidelines
- Develop practical test cases and test data based on customer scenarios
- Execute test cases, identify defects, deviations, and report results
- Perform peer reviews of Test cases, test data, and Test designs
- Work in a collaborative team setting with effective communication
- Understand the company's QMS standards
- Prepare documents complying with QMS guidelines
Requirements
- Bachelor's degree in Engineering, Computer Science, or related field
- 3+ years of experience in software validation or related field
- Thorough understanding of validation principles, methodologies, and regulations like GAMP, FDA
- Experience in risk assessments and developing risk-based validation strategies
- Proficiency in creating validation documentation: plans, protocols, reports
- Familiarity with software development life cycle (SDLC) and testing concepts
- Strong analytical and problem-solving skills
- Excellent written and verbal communication
- Ability to work both independently and collaboratively in a dynamic environment
- Detail-oriented with a focus on delivering high-quality work
ValGenesis Mission
ValGenesis transformed the life sciences industry in 2005 with the introduction of the first digital validation lifecycle management system. ValGenesis VLMS set the benchmark for compliance-based validation activities, which is still widely recognized.
Continuing the legacy, ValGenesis is expanding its digital transformation platform to provide comprehensive solutions beyond validation. The company combines its specialized systems with top-notch consulting services to assist in meeting regulatory requirements and quality standards.
Joining the Team
- Customer success drives the team, with a focus on improving human life quality through life sciences
- Teamwork is key, fostering open communication, full support, and a proactive attitude to get things done
- Embracing innovation, ValGenesis aims for growth, pushing boundaries in product development and personal advancement
- Setting high standards, the company strives to lead as the top intelligent validation platform in the industry
Work Environment
ValGenesis' Chennai and Bangalore offices operate on-site, enhancing creativity, community, and collaboration through in-person interactions. The company values this approach for future success.
ValGenesis promotes equal employment opportunities based on merit, seeking the best candidates for every role. Candidates are evaluated without bias towards race, religion, gender, or other protected characteristics.
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