Reliability Engineer II

Artech Information Systems LLC

Warsaw, IN

Reliability Engineer II

Core Technical Skills (Top 3)

Writing Validation Master Plans (VMP) and executing IQ/OQ/PQ protocols with minimal guidance
Understanding of software validation (GAMP 5)
Knowledge of automation systems validation (equipment + controls)

Primary Responsibilities

Lead validation activities for installation, qualification, and lifecycle management of automated manufacturing systems
Develop and execute VMP, IQ, OQ, PQ for a new automated shot peening system
Perform risk-based validation (ISO 14971) ensuring compliance and traceability
Support validation/requalification of an automated rod cell (machining, bending, inspection, autocorrection system)
Conduct software/controls validation and data integrity assessments
Support facility & utility qualification impacts (compressed air, RO/DI water, equipment relocation/reconfiguration)
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GAMP 5
Coordinate validation activities while minimizing disruption to production
Support transition into scale-up and new product line qualification

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Vacancy posted 1 day ago

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