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Process and Validation Engineer

  • October 29, 2025
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Job Location: Orland Park, IL 60462

Job Duties: 

  • Provide technical guidance in the design, system specification, project management, commissioning and validation, and start-up of various processes and equipment.
  • Coordinate equipment commissioning and validation activities, ensuring compliance with regulatory and quality standards.
  • Perform GxP assessments on assets to evaluate complexity and impact toproduct/process SQuIPP
  • Develop C&Q life cycle documentation viz., User Requirement Specifications, Verification and Qualification protocols (IQ/OQ/PQ), Requirement Traceability Matrices, summary reports, etc., for process and manufacturing equipment using Kneat
  • Conduct temperature mapping activities on CTUs viz., -80 C and -20 C freezers and refrigerators using Ellab data loggers
  • Assisted in execution of cleaning verification studies of process tanks, UF/DF Skids, and chromatography skids
  • Collaborate with SMEs to investigate deviations viz., Out of Specifications (OOS), procedures, and implement resolutions through CAPAs.
  • Identify gaps and update engineering design documents such as P&IDs, Process Flow Diagrams (PFDs) through change controls.
  • Author Request for Proposal (RFP), Request for Information (RFI) for the CAPEX/OPEX projects
  • Develop and maintain project documentation, including project plans, project schedules, status reports, and risk assessments.

Requirements: 

Education:

Master of Science Degree in Mechanical Engineering, or Industrial Engineering, or foreign equivalent.

Experience:

Minimum one year of experience as Validation Engineer in reviewing FAT and SAT protocols; development of commissioning and qualification protocols; reviewing piping and instrumentation diagrams (P&IDs) and general arrangement (GA) drawings; executing validation studies; and conducting risk analysis and preparing mitigation plans using FMEA and HAZOP methodologies for process equipment.

Skills:

FAT and SAT protocols, Validation Master Plan (VMP), PID tuning, and SIP cycle development for autoclaves.

 

To apply: Send resume to HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, 5th Floor, Orland Park, IL 60462. Ref # PVKD2025