Process Engineer

Title – Process EngineerLocation – Onsite - Richmond, IL 60071Duration – 5 months on W2 with high possibility of extension based on performance and depending on business needsTop 3 must have skills:Degree in engineeringProcess Validation (IQ/OQ/PQ), Risk Management (FMEA)13485 knowledge/experienceLooking for a qualified Engineer capable of leading a cross-functional project team and executing on design technical documentation.1) Product of Servicesa. Project Managementi. Manage weekly tasks and updates with the project team.ii. Coordinate on-site teams regarding process validation and equipment installations.b. Design & Sustainmenti. Author and review DHF artifacts including:Process Validation Owner: Installation and Operation Qualifications (IQ/OQ) and Performance Qualification (PQ)Risk Management, pFMEADesign Transferii. Understanding of statistical analysis, Design of Experiments (DOE), and Test Method Validation (TMV)c. Desired, not required, product technical understanding:i. Blending; formulations, mixing dynamics, tank designii. Filling/packing; liquid dispensing, capping, labeling equipment, packing assemblyiii. Measurement systems; UV Spectroscopy, pH, Viscometer, moisture analyzerd. Generali. Proficient in Microsoft Officeii. Basic understanding of quality systems, e.g. ISO9001, ISO134854) Minimum Qualificationsa. Requiredi. bachelor's degree in engineering or related degree.ii. 2+ years' experience in a regulated industry with design controls requirements.