Process and Validation Engineer

Responsibilities:

• 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.