Senthil Thiruvengadam
Irvine
Summary
Exceptionally dependable and well-trained Facilities Engineer, Quality Engineer and Validation engineer and Technical document writer with vast experience and various system specializations in facilities & utility installation and validation, Process validation, Automated manufacturing lines validation, E beam sterilization process validation, and industrial management. Lead validation projects and complete all associated project documentation in line with regulatory expectations, Manage, coordinate, and guide the execution of the site validation team. Develop and write commissioning, qualification and validation documents following established standards and templates. Managing, programming and monitoring the building automation system (BAS)/Environmental monitoring system (EMS) to control the environmental conditions to improve the Aseptic manufacturing processing. Develop inspection methods to analyse product quality. Troubleshoot in the event of abnormal testing results, issues identified by other staff members. Perform and conduct P&ID walk-downs and verification of system drawings. Time management, good written communication skills and technical knowledge, analytical thinking and enthusiasm for working in a team. Working on Non-Conformance, CAPA actions, Audit findings and Collaborate with the process, engineering, automation, and facilities team. Plant layout planning and design, concept and detailed layout generation, cross-functional design review, construction engineering, project management, Front end engineering (FEED) and Detailed design, Green and Brownfield project design and execution, and project proposals. Planning and project scheduling, prepare project budget, CAPEX and OPEX, communicating with customers and contractors. Adept at handling multiple projects simultaneously, whether working independently or as part of a team. Conscientious and mindful of all local state and federal safety standards. Strong working knowledge of GXP, ISO, FDA, ISO13485, IEC 60601 and 62304 and cGMP regulations, change control and documentation practices. Knowledge in PLM like Windchill, Adaptiv, cPDM and QMS.
Overview
2024
2024
years of professional experience
2006
2006
years of post-secondary education
1
1
Certification
Work History
Project Manager, Quality and Validation
Johnson & Johnson
3 2022 - 12.2023
- Working as validation and quality manager for Johnson and Johnson
- Installation and execution support of ISO standard cleanroom, Controlled non-classified room, General manufacturing area
- Installation and execution support of utilities that required for manufacturing and environmental monitoring such as compressed clean dry air, vacuum system, cold and hot water supply, HVAC, and building automation system
- Managing and monitoring the building automation system (BAS)/Environmental monitoring system (EMS) to control the environmental conditions to improve the Aseptic manufacturing processing
- Develop and write of master validation plan, URS, IQ/OQ/PQ protocols, reports, SOPs, and work instruction, reviewing to the customers, and getting approval through document control systems like QDMS and agile
- Prepare SOP for product test method, process validation, product quality monitoring
- Perform validation execution for product, manufacturing equipment, E bean sterilization process, facility and utility, and reports generation for review and regulatory approval
- Prepare engineering change control and document change control documents and reviewing to the customers and getting approval thru document control systems like QDMS and agile
- Plans, prioritizes, assigns, supervises, reviews, audits, and participates in the work of staff responsible for Commissioning, Qualification, and Validation (CQV) activities for a wide variety of projects
- Manage monthly, quarterly, and bi-annual quality reviews (Internal and Customer joint reviews) to assess if the QMS continues to meet established regulatory compliance requirements and assess opportunities for improvement
- Perform the non-conformance (NC) and CAPA root cause analysis, investigation and complete product review and coordinating with stakeholders for NC and CAPA closure
- Support the quality issue escalation processes (internal and customer) as required
- Support external audits, Customer audits, Internal audits as it relates to the CAPA and NC processes
Facilities Engineer, Quality and Validation
Flextronics
06.2018 - 03.2022
- Installation and execution support of ISO standard cleanroom, Controlled non-classified room, General manufacturing area, manufacturing lines installation and areas separation for inventory, SFG, FG and material review board & quarantine
- Installation and execution support of utilities that required for manufacturing and environmental monitoring such as compressed clean dry air, vacuum system, Nitrogen gas, cold and hot water supply, HVAC, and building automation system
- Installation and execution of the Product sterilization bunker/vault and flexible conveyor for sterilization processing
- Develop and write of master validation plan, URS, IQ/OQ/PQ protocols, reports, SOPs, and work instruction, reviewing to the customers, and getting approval through document control systems like QDMS, Agile and Kneat validation software
- Perform validation execution for manufacturing equipment, E bean sterilization process, facility and utility, and reports generation for review and regulatory approval
- Perform Factory acceptance test (FAT), Site acceptance test (SAT), facilities and utility commissioning according to original vendor equipment manufacture specifications
- Prepare engineering change control and document change control documents and reviewing to the customers and getting approval thru document control systems like QDMS and agile
- Plans, prioritizes, assigns, supervises, reviews, audits, and participates in the work of staff responsible for Commissioning, Qualification, and Validation (CQV) activities for a wide variety of projects
- Preparing impact assessment, FEMA and rev up the documents and re-execution of commissioning and validation
- Planning and scheduling the project, interacting with subcontractors and clients/customers to complete the project within the planned schedule
- Preparing and controlling the master facility plant layout as per manufacturing process flow, material flow, and lean requirements for ADC product 65MM/Year project
- Develop inspection methods to analyse product quality, improve product quality by making recommendations for change, ensure products adhere to company and industry quality standards
- Brainstorm ideas to create solutions for identified problems, formulate a strategic plan to increase productivity in the business, document results and findings after inspections are carried out
Validation/Quality Engineer
Procter & Gamble
02.2014 - 05.2018
- Prepare manufacturing plant layout as per good manufacturing process and lean requirements
- GMP manufacturing cells installation execution support and coordination with the vendor and customer
- Fabric and home care manufacturing raw material and inventory storage tank, conveyors installation execution, and commissioning
- Execution of factory acceptance test (FAT), site acceptance test (SAT), facilities and utility commissioning according to original vendor equipment manufactures specifications
- Conduct gap analysis with existing plant layout as-built and proposed expansion layouts to save the project duration and cost
- Perform commissioning of pipes, ducts, conveyor and dust collection baghouse, preparation of process flow, and risk assessment/FEMA
- Prepare quality standard documents, SOPs, and work instructions
- Prepare commissioning reports, coordinate with vendors and customers
- Prepare and review equipment cleaning log, GMP area cleaning log sheets
- Develop inspection methods to analyse product quality, improve product quality by making recommendations for change, ensure products adhere to company and industry quality standards
- Work together with relevant teams and departments to improve products, formulate a strategic plan to increase productivity in the business
- Implement a working system to ensure conformity and accuracy in the production process, document results and findings after inspections are carried out
Validation/Quality Engineer
Unilever
09.2009 - 01.2014
- Prepare master validation plan, URS, IQ/OQ/PQ protocols, reports, SOPs, and work instruction, reviewing to the customers and getting approval through document control systems like QDMS and agile
- Review equipment Cleaning Logs (Line Clearance), cleanroom cleaning log, change controls, Non-conformance's documentation, work orders, Manufacturing Batch Records, and SOPs
- Prepare engineering change control and document change control documents and review to the customers and get approval thru document control systems like QDMS and agile
- Perform factory acceptance test (FAT), site acceptance test (SAT), facilities and utility commissioning according to original vendor equipment manufacture specifications
- Prepare manufacturing plant layout as per good manufacturing process and lean requirements
- Tea manufacturing raw material and inventory storage bulk tank installation execution, commissioning
- Perform gap analysis with existing plant layout As built and proposed expansion layouts to save the project duration and cost
- Perform commissioning of Pipes, ducts, conveyor, and cable tray supporting structures dust collection baghouse supporting structure, prepare of process flow, and risk assessment/FEMA
- Prepare of commissioning reports, coordinate with vendors and customers
- Prepare and review of equipment cleaning log, GMP area cleaning log sheets
- Develop inspection methods to analyse product quality, improve product quality by making recommendations for change, ensure products adhere to company and industry quality standards
- Implement a working system to ensure conformity and accuracy in the production process, document results and findings after inspections are carried out
Potential Service Consultants
06.2006 - 07.2008
- Manyata Soft Park for Lucent Technology: It is a commercial building consisting of two blocks and multi-level car parking with two basement floors and ground and six floors for office purposes
- It has been designed as a flat &panel slab system with Wind & Seismic analysis
- West End Capital It Campus: Commercial Building with two towers
- It has two basement floors, ground and nine floors for IT purposes
- It has been designed as a waffle slab system with Wind & Seismic analysis
- Mantri Espana - Mantri Developers: Residential Apartment with 18 blocks has two Basement, Ground and 13, it has been designed as a shear wall system with wind & seismic analysis
- GMR International Airport Hotel, Hyderabad: Commercial building for various use
- It Consists of basement floors and ground and six floors
- It has been designed as a waffle slab & flat slab system with Wind & Seismic analysis
- OM CON RD-Rain Forest: Residential Building with 13 blocks
- It consists of two Basement floors, ground and 30 floors with Club Houses, Pools, Tennis courts, etc
- It has been designed as a beam and slab system with Wind & Seismic analysis
Rasi construction company
05.2002 - 05.2004
- Residential Apartment, Park View Flats: Residential Apartment with Ground & four Storey has been designed as a beam and slab system
- Shopping Complex: It is a commercial building, consisting of ground and three floors for commercial purposes
- It has been designed as a one-way ribbed slab system
- Residential Apartment, Sunshine Flats: Residential Apartment with Ground & five Storey has been designed as a beam and slab system
Education
Master’s Degree - Structural Engineering
Satyabhama University
Bachelor’s Degree - Civil Engineering
University of Madras
Diploma Degree - undefined
Technical Education Board
Skills
Primavera
STADD pro
AutoCAD
MS Office
Project Management
Project Planning
Risk Management
Project planning and development
Project tracking
Schedule Management
Work flow planning
Project Scheduling
Technical Support
Cost Control
Client Relations
Document Management
Data Analysis
Certification
Project Management Professional (PMP), https://www.bing.com/ck/a?!&&p=d597148f1c98d639JmltdHM9MTcwNzk1NTIwMCZpZ3VpZD0wOWFjNTAxMi03ZDljLTYzMDEtMGRiMS00NDM0N2MyZTYyYTImaW5zaWQ9NTI1Nw&ptn=3&ver=2&hsh=3&fclid=09ac5012-7d9c-6301-0db1-44347c2e62a2&psq=pmp+certification&u=a1aHR0cHM6Ly93d3cucG1pLm9yZy9jZXJ0aWZpY2F0aW9ucy9wcm9qZWN0LW1hbmFnZW1lbnQtcG1w&ntb=1
Timeline
Facilities Engineer, Quality and Validation
Flextronics
06.2018 - 03.2022
Validation/Quality Engineer
Procter & Gamble
02.2014 - 05.2018
Validation/Quality Engineer
Unilever
09.2009 - 01.2014
Potential Service Consultants
06.2006 - 07.2008
Rasi construction company
05.2002 - 05.2004
Bachelor’s Degree - Civil Engineering
University of Madras
Diploma Degree - undefined
Technical Education Board
Project Manager, Quality and Validation
Johnson & Johnson
3 2022 - 12.2023
Master’s Degree - Structural Engineering
Satyabhama University
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