Katalyst CRO
Overview
Join to apply for the
Validation Engineer
role at
Katalyst CRO 1 week ago Be among the first 25 applicants Responsibilities
Author/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 systems
Ultrasonic Washer. Barcode Scanner. Bio-Burden Hood. Auto Cannula Sorter. Air 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. Automatic 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. Seniority level
Associate Employment type
Contract
#J-18808-Ljbffr
Join to apply for the
Validation Engineer
role at
Katalyst CRO 1 week ago Be among the first 25 applicants Responsibilities
Author/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 systems
Ultrasonic Washer. Barcode Scanner. Bio-Burden Hood. Auto Cannula Sorter. Air 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. Automatic 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. Seniority level
Associate Employment type
Contract
#J-18808-Ljbffr