Muthu Mohandas Email & Phone Number

Kellyville, NSW, AU

Sydney, New South Wales, Australia

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.

Sydney, Australia

• Engineering & Manufacturing OperationsProvided engineering support, maintenance and troubleshooting of facility and production equipment’s in cGMP facility.Project Management from concept to completion, including.

Sydney, Australia

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

Sydney, Australia

• 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.

Singapore

• 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.

Penang, Malaysia

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

Banglore, India

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

Chennai, India

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.

Bachelor'S Degree, Mechanical Engineering

Bachelor'S Degree, Mechanical Engineering

Biologics, Pharma, Medical Device Manufacturing In Regulated Environment, Biologics / Pharma / Medical Device

Secondary School Education, Physical Sciences