Software Engineer

What you will do:

• Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
• Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
• 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 Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix.
• Perform impact assessments and change control activities for validated systems.
• Provide training and guidance on CSV processes and best practices.
• Maintain validation documentation in alignment with company procedures and regulatory expectations.

What you will need-

Required:

• Experience- 2yrs to 5 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
• Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
• Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.

• Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
• Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
• Excellent documentation, reporting, communication, and project management skills.