Validation Engineer
hace 6 días
Key Responsibilities
Execute and review Process Validation (PV) activities (Characterization, OQ, PQ – non-cleaning)
Support Equipment Qualification & Computer System Validation (CSV) (URS, FAT, IQ, OQ, PQ, TMV – non-laboratory)
Support validation strategies and requirements flow-down from design to manufacturing
Develop and maintain risk management documentation (pFMEA)
Investigate manufacturing events and support product disposition
Analyze and trend manufacturing defects and nonconformances
Support Design Transfer activities
Collaborate cross-functionally with Engineering and Manufacturing
Perform basic statistical analysis (Minitab preferred)
Qualifications
Bachelor's degree in Engineering (Mechanical, Electrical, or Chemical preferred)
2+ years of experience in validation life cycle process, Equipment Validation and Process Validation
Experience in regulated or medical device manufacturing environments
Knowledge of medical device regulations
Availability to work extended shifts, weekends, and holidays as required
Ability to work full-time onsite for the duration of the project
This is a project-based opportunity (~5 months) with immediate impact in a regulated environment.
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