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Validation Engineer
1 month ago
JOB RESPONSIBILITES INCLUDE BUT NOT LIMITED TO:
- Work with our control system programmers to develop and execute factory acceptance software test documents.
- Work as an integral member of a project team.
- Interface with our 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 the company 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 for field visits in a timely and professional manner. This will include field reports, daily labor logs, invoices, and expense reports.
- Keep current with the latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
- 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.
- Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
- 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 be willing and be capable of climbing ladders and entering restrictive spaces.
- Must understand computer system validation including knowledge of GAMP 5 and CFR 21 Part 11.
- Minimum of a four-year degree in engineering, engineering technology, science, or 5 to 7 years of related experience.
- Must possess a valid driver's license.
- Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
