Validation Engineer
L.J Gonzer Associates is looking for individuals to join our pool of qualified candidates for potential assignment as a Validation Engineer. -Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for Glatt equipment and control systems-Work with Glatt's control system programmers to develop and execute factory acceptance software test documents-Work as an integral member of a project team-Interface with the Glatt equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development-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-Coordinate the efforts of the personnel involved during on-site qualification. This would include the various engineering disciplines from within Glatt and/or personnel from the Glatt equipment manufacturing companies-Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing-Prepare documents of field visits in a timely and professional manner.This will include field reports, daily labor logs, invoices, and expense reports-Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications-Develop, maintain, and enhance positive interpersonal relationships with staff members of the Glatt Group worldwide-Perform other duties as assigned by management