Scope of systems and equipment include Computer systems (BMS,EMS,SCADA and all Equipment HMI and associated hardware and software configurations), Bio Processing Equipment, Purified Water and WFI systems, Single use systems, Filling and Packaging systems, Parts washing systems, Lab equipment’s – (PD, MTD, QC Lab), Mech. Equipment (AHU, Chilled Water, FCU,CA, Hydraulics (HW,CW piping), sewage and waste water systems.Developed and executed commissioning plans, including strategies, schedules, resources, and milestones, integrating into project timelines.Coordinated with stakeholders to integrate commissioning activities into schedules, fostering communication and teamwork.Collaborated with engineering teams to incorporate commissioning requirements into design and construction phases, ensuring compliance with standards.Provided technical expertise in commissioning processes for systems across multiple engineering disciplines.Led multidisciplinary commissioning team, offering guidance and mentorship to meet project objectives and promote collaboration.Implemented quality assurance processes to verify commissioning activities met regulatory requirements and industry standards.Developed and maintained comprehensive documentation, including plans, trackers, reports, and test procedures, ensuring accuracy and completeness.Identified potential risks and issues, developing mitigation strategies and addressing technical challenges to minimize project delays.

• Engineering & Manufacturing OperationsProvided engineering support, maintenance and troubleshooting of facility and production equipment’s in cGMP facility.Project Management from concept to completion, including budgeting, scheduling, procurement, and vendor management.Worked on process optimization, equipment qualification, and facility upgrades to support pharmaceutical manufacturing operations.Worked with equipment vendors / contractors for SLA, troubleshooting, maintenance and calibration for facility and production equipments. [Facility equipment / systems: BMS, EMS, WFI system, LP, HP compressors, N2 generator, dehumidifiers, HVAC equipment, Trade. Operation equipment / systems: Spray dryer, solution preparation, blenders, millers, Encapsulator, primary and secondary packaging equipment, QC and R&D equipment, Eurotherm data recorders, stability chambers]Developed and implemented strategic plans to optimize production processes, reduce downtime, and improve overall equipment effectiveness (OEE).Troubleshoot technical issues, resolve deviations, and implement corrective and preventive actions (CAPAs). Performed risk assessments, developed validation protocols, specifications (URS,FS,DS) and executed validation activities (IQ,OQ,PQ,PV) for equipment, processes, and utilities.Proficient and experienced in CSV Projects based on GAMP assessment (category - GAMP 1 to 5)Authored SOPs, Forms, Templates, technical documentation, including engineering drawings, specifications.Performed Annual Product Quality review (APQR) for maintaining validated state of facility and production equipment.Monitored cGMP cleanroom environment condition through BMS and EMS systems.Provided technical support during regulatory inspections and audits, ensuring compliance with FDA and other regulatory agencies.Provided leadership and mentorship to engineering & operations staff, training, fostering a culture of accountability, collaboration, and professional growth.

Validated and Qualified automated system for manufacturing Test Kits.Worked on Process Improvement tasks for better yield.Oversee operations document review and management.

• Managed Maintenance and Calibration programs for process and equipment’s & facilities used in clean room environment.• Scheduled and executed Maintenance and calibration tasks coordinating with external contractors.

• Manufactured contact lens in compliance to ISO 13485 and 21CFRPart820.• Prepared, Reviewed and approved SOP, WI, validation documents.• Conducted product quality reviews for continuous improvements.• Investigated NCR, Customer complaints and worked on action(s) for preventing them.• Tracked NCR, CAPA, and Change control with Trackwise System• Supported Quality Control operations for AQL Sampling checks, Visual Inspection, Batch review, DHR release.• Tracked and monitored Quality defects and prepared weekly reports.• Supported External audit and performed internal audits for ensuring compliance.• Prepared and executed protocols and reports for validation and Qualification (URS,FS,DS,FRA,IQ,OQ,PQ) of new systems, new products, process validations.• Prepared QSR and reviewed documentation, deviations, change control.• Performed CSV Validations in compliance to GAMP 5 and 21CFRPart11.Completed Projects:• New Product Introduction – Contact Lens Manufacturing – 10 Lines• Commissioning and Qualification – Primary and Secondary Packaging system.• Laser System Upgrade – Validation and Qualification• Vision system rejects reduction – 3% to1.5%• Annual requalification of Sterilizers• OEE Improvement from 80% to 87%• Product Defect reduction – Major A and Major B defects from 1500PPM to 800PPM• Report on multiple lens – Waste reduction Project – 3% to 0.5%• Time Study – Cycle time reduction from 5.5 to 4.8 for 12% additional manufacturing output – Reducing nonvalue added automated activities.• PVA Dosing Pump Reduction – Reduced parts consumption project – 50% savings on part changing – Control Plan implementation.• PM turnaround time reduction from 7 hours to 6 hours – additional production of 78K Lenses / Month.• Quality Control - KPI Product Performance Analysis, Monitoring.• CSV – Sealing Equipment Computer and Software validation.• Cleaning validation of Linear Tables using Hydrogen Peroxide• Qualification of IPI in process vision system

Product Transfer of Flexible PCB for mass productionValidation and Verification of Gerber drawings, design validation, process validation, mapping process flow, resolving process issues.

As a Quality engineer, framed Quality Plans, Statistical Techniques for process capability, Sampling Plans for Quality control, maintain QMS, supplier audits.

Process engineer in end of line operations from molding until IC Testing. Worked on Continuous improvement project, process capability analysis. Worked with suppliers for engineering improvements.