Description

You will lead validation activities to ensure compliance and system reliability across product development and process improvements.

Responsibilities

• Develop and execute validation plans, protocols, reports, and Requirements Traceability Matrices.
• Design and perform validation tests, including GxP application flows, to verify system functionality.
• Conduct root cause analysis for failures and implement corrective and preventive actions (CAPAs).
• Manage documentation for SOPs, change control records, deviations, and Validation Summary Reports.
• Collaborate with cross-functional teams and vendors to define requirements and ensure regulatory compliance.

Required Skills

• 6+ years of experience in validation engineering within pharmaceuticals, medical devices, or biotechnology.
• Deep knowledge of FDA, ISO, and GMP regulatory requirements.
• Proficiency using HP ALM for writing, approving, and executing test scripts.
• Solid manual QA work experience.
• Experience performing risk assessments and developing mitigation strategies.
• Strong analytical skills for evaluating complex data sets and identifying trends.
• Proven ability to manage Change Management and Deviation processes.
• Any graduate degree.

Preferred Skills

• Working knowledge of Agile methodology.
• Experience with onsite-offshore coordination.

Key Skills

Education

ANY GRADUATE