**Process Validation Engineer (Medical Devices)**



+ **Location** : 100% ONSITE - Waltham, MA (02451)
+ **Duration:** 12 month contract - (extension potential)
+ **Pay** : Negotiable depending on DIRECT related experience Up to $45 - $50/hr
+ **Type:** W2 contract ONLY - (C2C OR THIRD-PARTY arrangements will NOT be considered)
+ **Work Authorization:** Must be currently located and authorized to work in the United States without sponsorship requirements.


**Job Summary and Required Experience:**


+ Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
+ Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.
+ Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause inve...