Validation Engineer - Gonzer Associates, L. J.
Ramsey, NJ
About the Job
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
- Bachelor Degree in engineering, engineering technology, science or 5 to 7 years of related experience
- Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential
- Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code
- Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions
- Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.)
- Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable
- Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part 11
Source : Gonzer Associates, L. J.
