Validation
IQ/OQ/PQ, test method validation, software validation.
01 —Role overview
Validation specialists verify that medical device manufacturing equipment, processes, and software perform consistently within specification.
02 —Key responsibilities
What you'll do.
- 01Author and execute IQ/OQ/PQ for manufacturing equipment
- 02Validate test methods and software per CSV/Part 11
- 03Maintain validation master plans and traceability
- 04Partner with QA on deviation and change control
- 05Support sterility and packaging validations
03 —Skills & tooling
In demand.
IQ/OQ/PQTMVCSVGAMP 5Statistical MethodsISO 13485/QMSFDA21 CFR Part 11
04 —Experience
Typical range
3–10 years
05 —Related roles
More in Medical Devices.
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