Actalent
US - California - Irvine
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Provide hands-on mechanical engineering support for automated IV bag manufacturing equipment, focusing on reliability and process optimization. Lead troubleshooting, root cause investigations, and equipment modifications within a GMP-regulated environment.
Requirements: Requires a Bachelor's degree in Mechanical Engineering and 3+ years of pharmaceutical or 5+ years of regulated manufacturing experience. Proficiency in SolidWorks, AutoCAD, and experience with equipment qualification (IQ/OQ/PQ) is essential.
Key Skills: SolidWorks, AutoCAD, GMP, Root Cause Analysis, CAPA, Equipment Validation, FMEA, Mechanical Design, Pneumatics, Heat Transfer, IQ/OQ/PQ, Lean Manufacturing, Reliability Engineering, Thermal Welding, RF Welding, Cleanroom Operations
Benefits: Medical, Dental, Vision, Critical Illness, Accident, Hospital, 401(k) Retirement Plan, Life Insurance, Short and long-term disability, Health Spending Account (HSA), Transportation benefits, Employee Assistance Program, Paid Time Off
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