Katalyst Healthcares and Life Sciences
Validation Engineer
Katalyst Healthcares and Life Sciences, Skaneateles, New York, United States, 13152
Job Description:
uthor/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report. Perform IQ/OQ/PQ test execution for manufacturing equipment. Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation. Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements. In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211). Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies. Investigate and resolve software or system-level issues found during validation or manufacturing use. Experience in ATE system validation in the medical device industry. Measurement System knowledge. Hands-on experience with few of the below listed systems:
Ultrasonic Washer. Barcode Scanner. Bio-Burden Hood. uto Cannula Sorter. ir Blockage Tester. Lasermike / Bench Top Laser Mike. Farrel Mixer Controller and Puller. Puller/Cutter. Rubber Slicer. Extruder W/ Water bath. Flow Tester. Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer. Bladder Sorter Auto Machine. utomatic Tube Set Assembly Machine. Snap Cap Welding Machine. Longford Labeler/ Universal Labeling System/ Labeling Machine. Herrmann Welder. Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester. Battery Simulator. Battery Module Communication Test Fixture. Keypad misuse test fixture. Requirements:
Bachelor's or Master's in Biomedical Engineering, Instrumentation Engineering, Electrical Engineering, Measurement Engineering, Mechanical Engineering, or related field.
uthor/Develop Risk Assessment, User Requirement Specification, Validation Plan, IQ/OQ/PQ, SOP, FMEA, RTM, and Validation Report. Perform IQ/OQ/PQ test execution for manufacturing equipment. Experience in Test Method Validation, Gage R&R, Minitab, and Process Validation. Hands-on experience in GAMP 5, FDA 21 CFR Part 11, Data Integrity, ALCOA requirements. In-depth understanding of FDA regulations (21 CFR Parts 820, 210/211). Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation requirements and risk-based testing strategies. Investigate and resolve software or system-level issues found during validation or manufacturing use. Experience in ATE system validation in the medical device industry. Measurement System knowledge. Hands-on experience with few of the below listed systems:
Ultrasonic Washer. Barcode Scanner. Bio-Burden Hood. uto Cannula Sorter. ir Blockage Tester. Lasermike / Bench Top Laser Mike. Farrel Mixer Controller and Puller. Puller/Cutter. Rubber Slicer. Extruder W/ Water bath. Flow Tester. Printex/ Zebra Printers/ Printronix Printer/ Image Pouch Printer. Bladder Sorter Auto Machine. utomatic Tube Set Assembly Machine. Snap Cap Welding Machine. Longford Labeler/ Universal Labeling System/ Labeling Machine. Herrmann Welder. Uson Leak Tester/Two Up Tester/Coiled Fill Port Tester. Battery Simulator. Battery Module Communication Test Fixture. Keypad misuse test fixture. Requirements:
Bachelor's or Master's in Biomedical Engineering, Instrumentation Engineering, Electrical Engineering, Measurement Engineering, Mechanical Engineering, or related field.