Validation Engineer Job

Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Requirements Traceability Matrix, Validation Summary Reports, Standard Operating Procedures, Change Control Documentation, and Risk Assessment reports; also Manufacturing Process and Equipment
Managing and coordinating all aspects of the validation activities, including project planning, developing validation strategies, document development and document reviews.
Write and execute IQ and OQ protocols.
Conducting system compliance reviews.
Overseeing system change requests and associated documentation.
Managing documentation logs and document storage.
Maintaining SOPs pertaining to the Quality Management System.
Utilization of a risk-based approach (GAMP5) to determine the validation requirements.
Communicating with necessary vendors to ensure project requirements are being met.
Configuration specifications generation detailing the specific configuration of the systems / interfaces.
Project change control implementation in accordance with requirements, design and system changes.
Identify risks and clearly communicate them to project stakeholders.

Bachelor's Degree is required in Biomedical Engineering or Biomedical Sciences.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave