Computer System Validation/Software Testing Engineer

Job Title : Computer System Validation (CSV) / Software Testing Engineer Location : Pune, India Experience : 6 years Job Description : We are seeking an experienced Computer System Validation (CSV) / Software Testing Engineer to join our team. The ideal candidate will have a strong background in validating computer systems within regulated environments, ensuring compliance with industry standards and regulations. Key Responsibilities : - Develop and execute validation strategies for software systems, ensuring compliance with regulatory requirements (e.g., FDA, GxP). - Create and maintain validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), and Test Scripts. - Perform risk assessments and impact analyses on software changes and upgrades. - Collaborate with cross-functional teams to identify and resolve validation issues. - Conduct testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). - Review and approve software change controls and deviations. - Ensure compliance with internal quality management systems and industry best practices. - Provide training and guidance to junior team members on CSV and testing processes. Qualifications : - Bachelor's degree in Computer Science, Information Technology, or a related field. - 6 years of experience in Computer System Validation and software testing, preferably in a regulated industry (pharmaceutical, biotechnology, or medical devices). - Strong understanding of software development life cycle (SDLC) and validation life cycle. - Proficiency in testing methodologies and tools (e.g., Manual Testing, Automated Testing). - Familiarity with validation tools and techniques, such as GAMP 5 guidelines. - Excellent problem-solving skills and attention to detail. - Strong communication and interpersonal skills. Preferred Skills : - Certification in Quality Assurance (e.g., CQE, CQA) is a plus. - Experience with electronic records and electronic signatures (ERES). - Knowledge of agile methodologies and experience working in agile environments. (ref:hirist.tech)

Location: pune, IN

Posted Date: 2/21/2025