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Reliability Engineer II

Artech LLC

Warsaw, IN

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JOB DETAILS
SALARY
$45–$50 Per Hour
SKILLS
Automation Systems, Code of Federal Regulations, Data Analysis, Data Quality, Equipment Validation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Machining, Maintain Compliance, Manufacturing Management, Process Validation, Reliability Engineering, Risk, Software Validation, System Validation, Systems Administration/Management, Traceability, Validation Plan
LOCATION
Warsaw, IN
POSTED
4 days ago

Job Title: Reliability Engineer II
Job ID: 27102
Duration: 8 Months
Location: 2500 Silvers Crossing, Warsaw Indiana 46582
Pay Rate: $45.00 - $50.00/hr.
 

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

About the Company

A

Artech LLC

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