Job Description
Role Summary
The Validation Engineer is responsible for executing end‐to‐end validation and re‐validation activities for processes, test methods, equipment, tools, software, and measurement systems in compliance with quality and regulatory standards.
Key Responsibilities
Develop and execute Validation Plans, Protocols (IQ/OQ/PQ), and Reports.
Perform Process Validation, Test Method Validation (TMV), and periodic re‐validation.
Conduct Manufacturing Station Qualification and Tool Qualification.
Perform Measurement System Analysis (MSA) including Gage R&R.
Execute Non‐Product Software Validation (NPSV) as per software validation lifecycle.
Update validation documents and maintain records within the Quality Management System (QMS).
Collaborate with Manufacturing, Quality, and Engineering teams to support project needs.
Qualifications
Bachelor's degree in mechanical, Industrial, Biomedical, or related engineering field.
Strong understandin...