Process and Validation Engineer Job

• 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.

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.

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

Contact: HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, Orland Park, IL 60462. Ref # PVKD2025