Senior Validation Engineer - Pharma Industry

Job description and responsibility:

The Validation Engineer plays a critical role in ensuring that the client's QC solution meets regulatory, business, security, and technical requirements. The ideal candidates should have extensive hands-on experience as a test engineer as well as strong Pharma compliance knowledge under the SLDC/Agile framework. This role is embedded within the Core Agile Team and collaborates with Business Owners, BTQA, BUQA, and developers to execute validation deliverables under the Agile Development Life Cycle (ADLC) framework.

- Develop, refine, and execute test cases aligned with user stories and system specifications

- Validate software against business requirements and acceptance criteria using tools like Jira and qTest

- Identify, log, and track defects through resolution and Collaborate with developers and business analysts to clarify issues and retest fixes.

- Perform formal verification and validation activities.

- Ensure traceability of test cases to requirements and maintain audit-ready documentation.

- Author and maintain GxP-compliant validation documents such as test scripts, test plans, execution reports, sign-off documents, validation protocol, validation summary report and etc.

- Review and approve test cases routed via Qtest and Vera, ensuring alignment with validation protocols.

- Document defects, deviations, and resolutions in alignment with SOPs and change control processes.

- Work closely with Agile team members, including developers, business analysts, and quality representatives.

Required Skills and Experience:

Expert in testing, validation and compliance with strong communication skills in fast changing dynamic Agile delivery environment.

- Min 5 Yrs Experience in GMP validation as a test engineer.

- Min 3 yrs Experience using qTest and JIRA

- Strong understanding of GxP and regulatory standards in Pharmaceutical industry.

- Proven ability to lead the team and drive the efforts in tight schedule

- Excellent documentation and communication skills.

- Experience with TOSCA automation and Selenium is a big plus

• Location:Offshore (need to be able to go to office 3 times a week)