Process and Validation Engineer Job

• Provide technical support in the development of engineering documentation including system specifications, design reviews, commissioning document, and change controls.
• Prepare and execute C&Q protocols for process equipment, vessels, and clean utilities.
• Author and execute commissioning documents for equipment in compliance with Global Standards.
• Develop C&Q life cycle documentation viz., User Requirement Specifications, Verification and Qualification protocols (IQ/OQ/PQ).
• Read, interpret, and analyze engineering designs, Piping and Instrumentation Diagrams (P&ID), and process drawings with a keen attention to detail.
• Evaluate the feasibility, functionality, and safety of designs, identifying potential issues and proposing design improvements.
• Identify and update complex process flows, instrumentation, and equipment specifications to ensure project requirements are met.
• Coordinate with cross-functional teams to ensure successful completion of equipment performance testing and compliance with applicable regulations.
• Analyze performance test results and recommended corrective actions to optimize equipment functionality.
• Develop and implement continuous improvement tools such as lean, six sigma to optimize processes, reduce waste, and enhance productivity.
• Author Request for Proposal (RFP), Request for Information (RFI) for the CAPEX/OPEX projects.
• Support and oversee the team efforts through Design, Procurement, Construction, and CQV, ensuring the project meets goals for estimates, budget, cost, scope & quality.
• Facilitate risk management workshops to identify, assess, and prioritize project risks, and develop corresponding risk response plans.
• Draft Project Execution Plan, RACI (Responsible Accountable Consulted Informed) for on-going projects.
• Technical expertise in providing creative solutions that solve complex problems while ensuring adherence to project timelines and budget constraints.
• Use skills and tools including: ASTM E2500, cGMP, GAMP, Commissioning, Qualification and Validation of Complex Automated systems, Automation Check Outs, Lean Six Sigma Principles, Continuous Improvement, Measurement System Analysis, Statistical Process Control, MATLAB/Python for Data Analysis, Hazard and Risk Analysis (Fault Tree Analysis, FMEA), Change Controls. SCADA, PLC Programming (RSLogix 5000), Kneat, AutoCAD, P&ID, Process Flow Diagrams.

Education: Master of Science degree in Mechanical Engineering, or Validation Engineering.

Experience: Two years of experience in executing validation protocols (IQ/OQ/PQ) for facilities, utilities, and lab equipment; two year of experience in risk assessments using FMEA and HAZOP methodologies; two year of experience in PID tuning, alarm verification, I/O testing, and control sequence validation for automation systems.

Skills and knowledge: Skills in using FMEA and HAZOP methodologies; data-driven engineering assessments; and validation protocols (IQ/OQ/PQ) .

Contact: HR, MMR Consulting USA, Inc., 15255 South 94th Avenue, Orland Park, IL 60462. Ref # RSMMR2023

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology