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Reference Number: 14835-BZ
Job Description: Validation engineer for the validation of pharmaceutical process controls. Primary responsibilities will include: 1. Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company's equipment and control systems. 2. Work with company's control system programmers to develop and execute software test documents. 3. Work as an integral member of a project team. 4. Interface with equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development. 5. Field execution/testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing. 6. Coordinate the efforts of the personnel involved during on-site qualification. This would include the various engineering disciplines. 7. Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing. 8. Prepare documents of field visits in a timely and professional manner. This will include calibration reports, field reports, daily labor logs, invoices, and expense reports. 9. Keep current with latest cGMP's, Validation technology and procedures, PMA guidelines and related FDA publications.
Experience Level: Unspecified
Requirements: Engineering degree (EE would be best.) Experience in validating process control systems.
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