Validation Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Skaneateles, NY, 13152

Posted Date : 14 October 2025

Job Type : Other

Category : Mechanical Engineering

Occupation : Validation Engineer

Job Details

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:

Requirements:

Bachelor's or Master's in Biomedical Engineering, Instrumentation Engineering, Electrical Engineering, Measurement Engineering, Mechanical Engineering, or related field.