Vijay Shanmugam

• Responsible for Testing and qualification of standard systems (Configured-to-Order) as well as ETO (Engineered-to-Ordered systems both Upstream and Downstream Equipment) which were part of transfer projects from Germany to India.
• Part of Recent Transfer/NPI Project of Chromatography Systems from Havant, United Kingdom (Involved in Design, Quality (FMEA, APQP and ISO documents) and Testing/Qualification activities of the prototype)
• Prepared and executed Manufacturer test protocols.
• Preparation of Product Test Specification, Verification and Test Protocol, Calibration Plan, Test protocols for both Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
• Execution of Product Test Specification, Verification and Test Protocol, Calibration Plan, Test protocols in FAT and SAT.
• Execution of calibrations and Electric security test.
• Interacted with customers during FAT and participated in technical discussions.
• Managed customer and internal complaints regarding equipment quality and qualifications.
• Trained and Certified Internal Auditor for ISO:9001(2015), ISO:45001(2018) and ISO:14001(2015).
• Certified 5S Lead Assessor overseeing Internal and External audits for ABK-AOTS
• Developed diverse ISO-related documents like HIRA, Aspect/Impact, Needs and expectations to ensure compliance with ISO standards (ISO:9001, ISO:45001 and ISO:14001) across different Product lines.
• Prepare, Review and modification of standard operating procedures (SOPs) for various Process.
• Played an integral role in transfer projects, engaging in technical discussions and lending engineering expertise.
• Identified process improvement opportunities through data analysis, benchmarking and root cause analysis.
• Prepared reports on project progress, cost savings, and performance metrics associated with process improvements initiatives.
• Monitored operations against established KPIs ensuring compliance with standards set forth by company policies.
• Developed and implemented Lean Six Sigma methodology to reduce costs and improve efficiency.

• Managed and executed various projects in Biologics manufacturing plants 1-4, QC lab, and Biopharmaceutical development lab. Executed civil and mechanical completion projects, as well as utility and electrical installations. Additionally, responsible for the commissioning of building management systems and environmental monitoring system qualification.
• Contributed to the equipment's Design stage and attended related reviews for the new facility
• Involved in the complete qualification cycle of biopharmaceutical equipment (URS, SLIA, CLIA, DQ, Risk Assessment, Requirement Traceability Matrix, Commissioning, FAT, SAT, IQ, OQ, PQ, Legacy Equipment qualification, GAP analysis and Decommissioning)
• Attended Factory Acceptance Test (FAT) of below systems which covered mechanical, electrical, instrumentation and automation scope.

1. Purified Water Distribution systems (CN Waters, Navi-Mumbai).

2. Water for injection Distribution Systems (CN Waters, Navi-Mumbai).

3. Fermenter Systems, TFF systems (Biologics production Equipment).

• Involved in Site Acceptance Tests (SAT)/Commissioning of below systems which covered mechanical, electrical, instrumentation and automation scope

1. Purified Water generation/Distribution - CN Waters/Nilshan Nishotech

2. WFI generation/Distribution - CN Waters/BWT

3. Pure Steam generation and Distribution System (BWT/CN)

4. Fermenter systems (Sartorius/EF)

5. Homogenizer (GEA)

6. Continuous Centrifuge (Alfa Laval)

7. Single Use Mixing stations (Sartorius)

• Computerized System validation (GAMP5, 21CFR11, pharmaceutical guidelines)
• Planned and executed HVAC Qualification/Validation.
• Planned and executed preventive maintenance of equipment according to schedule.
• Planned and coordinated with vendor for AMC equipment PM.
• Attended equipment breakdowns at Biologics manufacturing plant.
• Managed the identification and upkeep of critical spares.
• Preparation of EAM-related SOPs and QMS documentation.
• Preparation and execution of equipment qualification (URS, DQ, IQ, OQ PQ) related documentations in EDMS as well as Hard Copy.
• Adapted equipment and facility to meet process needs.
• Monitoring and maintaining all utilities for Biologics manufacturing plant, Water plant during shift.
• Maintained relationships with stakeholders to ensure successful collaboration between internal teams and external partners.

• Monitored and maintained utilities for Biologics manufacturing plant during shift
• Ensured timely preventive maintenance of equipment through efficient planning and execution.
• Efficiently managed and organized AMC equipment PM in collaboration with vendor.
• Assisted in resolving equipment breakdowns at a Biologics manufacturing plant.
• Managed the identification and maintenance of critical spares.
• Prepared EAM related SOPs and QMS documentation.
• Preparation and execution of equipment qualification (URS, DQ, IQ, OQ PQ) related documentations.
• Adjusted equipment and facility according to process needs.
• Planned and executed HVAC validation through vendor coordination.