Software Engineer

What you will do:

• Develop and execute validation strategies and plans for new and existing computerized systems.
• Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessments; Validation Plans (VP); IQ/OQ/PQ Protocols and Reports; Traceability Matrix
• Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.
• Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs.
• Perform impact assessments and change control activities for validated systems.
• Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements and provide training and guidance on CSV processes and best practices.
• Maintain validation documentation in alignment with company procedures and regulatory expectations.
• Develop, review, and execute detailed test plans, test cases, and test scripts based on system requirements and design documents.
• Perform functional, integration, regression, and user acceptance testing (UAT) across various systems and platforms. Identify, document, and track defects through resolution using defect management tools (e.g., JIRA, HP ALM, Bugzilla). Analyze test results, generate test reports, and provide insights for continuous improvement of the software and testing process

What You Will Need-

Required:

• Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
• Experience - 2 years to 5 years
• Experience with validating systems such as LIMS, MES, ERP, QMS, SCADA, PLCs, and custom applications.; with test management tools (e.g., JIRA, HP ALM, TestRail); Exposure to automated testing tools (e.g., Selenium, QTP/UFT, Postman); Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
• Understanding of software development life cycle (SDLC) and risk-based validation approaches.
• Excellent documentation, communication, and project management skills.

Preferred :

• CSV certifications (e.g., ISPE, PDA) or GxP training.
• Experience in data integrity assessments and remediation projects.
• Familiarity with cloud-based systems and cybersecurity considerations.