Location
Noblesville
Job Type
Full-time
Posted
July 08, 2026
Job Description
Job Title: Process Validation Engineer
Job Description
The Process Validation Engineer leads validation activities for automation and equipment capital projects, drives process improvements, and ensures new equipment installations and process transfers are fully validated and ready for production in a regulated medical device environment.
Responsibilities
+ Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.
+ Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.
+ Maintain Agile documentation related to processes and equipment, including standard operating procedures (SOPs), flow charts, electrical drawings, 2D/3D drawings, equipment parameter lists (CP), and equipment logic programs (LCP)....
Job Description
The Process Validation Engineer leads validation activities for automation and equipment capital projects, drives process improvements, and ensures new equipment installations and process transfers are fully validated and ready for production in a regulated medical device environment.
Responsibilities
+ Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.
+ Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.
+ Maintain Agile documentation related to processes and equipment, including standard operating procedures (SOPs), flow charts, electrical drawings, 2D/3D drawings, equipment parameter lists (CP), and equipment logic programs (LCP)....