Role Title:Computer System Validation (CSV) Specialist / Validation Engineer
Company: Willware Technologies
Work mode: Bengaluru, Mumbai, Gurugram, Delhi
Key Responsibilities:- Perform Computer System Validation (CSV) activities in compliance with FDA and global regulatory standards.
- Validate IT systems used in medical devices domain ensuring adherence to GxP guidelines.
- Participate in mergers, acquisitions, divestitures, and system integrations, ensuring validation compliance.
- Prepare, review, and execute validation deliverables including:
- Requirements documentation
- Validation/Compliance Plans
- Test Protocols (IQ, OQ, PQ)
- Test Summary Reports
- Validation Reports
- Develop and review:
- Test plans and test cases
- UAT scripts
- Traceability Matrix (RTM)
- Design Specifications
- Conduct risk-based validation and ensure documentation aligns with regulatory expectations.
- Review test execution results, defects, and change records.
- Support infrastructure qualification activities.
- Collaborate with cross-functional and remote teams for multiple project deliveries.
- Ensure adherence to QA methodologies and best practices.
Required Skills & Experience: - 3+ years of experience in System Development Life Cycle (SDLC)
- 7+ years of experience in Computer System Validation (CSV) (depending on role level)
- Strong experience in FDA regulated / global regulated environments
- In-depth understanding of:
- GxP (GMP, GAMP, etc.) standards
- Risk-based validation approach
- Experience in:
- Mergers & Acquisitions (M&A) (Acquisition, Separation, Divestiture)
- Infrastructure Qualification (IQ)
- Hands-on experience in:
- Test script creation & execution
- Defect management and review
- Familiarity with tools:
- Strong documentation, communication, and stakeholder management skills
- Ability to work independently and in team environments
