Validation Engineer

Company : Katalyst Healthcares & Life Sciences

Job Description:

• 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 few of the below listed 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.

Apply Online