EQUIPMENT VALIDATION

Title: EQUIPMENT VALIDATION

Location: New York, NY - Remote

Contract : 1Year

• Equipment Validation Engineer: Design layout of equipment/materials in compliance with ISO, FDA, and GMP standards.
• Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).
• Research, study, compile and prepare material on quality control activities, processes and procedures.
• 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 Glatt 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 to climb ladders and to enter restrictive spaces.
• Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part 11.

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