BINDUKUMAR NELLORE KUMAR
Mississauga
Summary
Skilled mechanical engineer experienced in the field of cGMP Biopharmaceutical industry in Process, Production, Compliance and CQV activities. Knowledgeable in validation studies, validation strategies, feasibility studies, process capability, CAPA's, deviation and investigation studies. Expertise in drafting Engineering protocols, SOPs, Work Instructions, and various other technical documents. Sound knowledge of cGMP practices. Sound knowledge of the operation and troubleshooting of various kinds of biopharmaceutical equipment’s like chromatography skids (Akta Ready), Ultrafiltration & diafiltration skids, EBA columns, Compressed bed BPG columns, Tangential flow filters, Nano filters. Knowledgeable in commissioning and qualification of biopharmaceutical manufacturing upstream & downstream process including associated utilities such as CIP/SIP, clean steam, WFI, compressed air system. Skilled in CATIA V5, Autodesk Inventor and AutoCAD/ZWCAD.
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
17
17
years of professional experience
Work History
Validation Lead
Estee Lauder
03.2024 - Current
- Develop and execute engineering documents such as FAT, SAT, IOQ, PPQ and Cleaning validation protocols
- Assist with new launch development by being an integral part of the Change controls process
- Develop validation procedures and processes using established GxP and regulatory guidelines
- Lead and manage CSV activities
- Perform risk analysis on Cleaning validation needs
- Supported internal audit compliance inspection activities
- Perform deviation investigation and resolution for problems and issues encountered during field execution activities by initiating CAPA’s in quality platform
- Lead and manage Data Integrity activities, initiatives, and continuous improvements
- Provide validation expertise to various departments using a risk-based approach
- Interacting and coordinating with numerous departments such as Operations, Quality, CVE, IE, QE, Maintenance to ensure planned commissioning and qualification activities are executed smoothly
- Develop testing strategies to enhance and improve the quality of projects and systems
Engineering Consultant – CQV & CSV
Brevitas Consulting Inc.
08.2022 - 03.2024
- Review various technical documents such as FS, HDS, SDS to develop qualification protocols for process equipment
- Assist with development and review of CQV and CSV FAT supplements, executed protocols for B200 project
- Assist in deviation investigation and resolution for problems and issues encountered during field execution activities.
- Maintain and update a list of computerized GxP systems and conduct periodic reviews
- Develop and execute engineering documents such as FAT, SAT, IOQ, PPQ and CV protocols
Process Engineer
VPC Group
05.2019 - 03.2020
- Monitoring and studying various process parameters such as setup time, throughput time, Downtime of equipment, WIP studies, etc. in order to optimize the process
- Process capability study using process capability index (Cpk)
- Presenting weekly, and monthly process capability reports
- Analysis using a Process flow chart, fishbone diagram, and other tools
Manufacturing Specialist II (Team Lead) / Process improvement specialist
Therapure Biopharma Inc. / Resilience
05.2016 - 05.2019
- Engage and support new equipment performance specification development to enable and ensure long term performance expectations are met
- Participate in feasibility / feasibility cost assessments for new products
- Support manager in development and execution of robust, site-based process improvement plans for existing as well as new products and technologies
- Interact with consultants on company expectations and requirements relating to CSV and CQV activities by conducting regular meetings and review of deliverables
- Support in the analysis of process capability by using control charts and process capability index (Cpk)
- Sound knowledge of working in a GMP environment by following cGMP practices
- Train new employees on GMP/company standards and GMP equipments
- Sound Knowledge and understanding of the operation and troubleshooting of various kinds of machinery used to make protein enzymes like chromatography skids (Akta Ready), Ultrafiltration & diafiltration skids, EBA columns, Compressed bed BPG columns, Tangential flow filters, Nano filters, etc.
- Skilled in Troubleshooting GMP equipment during process runs to reduce downtime
- Implementation of Continuous improvement through PDCA cycle and 5S principle.
- Preparation of Engineering protocols, IQ/OQ/PQ and Cleaning validation protocols SOPs and work instructions, BPRs and BOMs by interacting with SMEs.
Production Technician
Silfab Solar Inc.
02.2016 - 04.2016
- Operation of various process equipment in the manufacture of solar panels
- Assisting the quality team to inspect the panels for any quality defects
- Preparation of production reports and quality charts
- Conducting flash tests on the solar panels to determine and check their power rating
Mechanical Engineer
BCIPL
10.2008 - 11.2014
- Preparation of drawings using Computer-aided drafting software, ZWCAD/AutoCAD, and process plan
- Orthographic Drawings (first angle projection) preparation with respect to Company standard guidelines/templates and GD&T and preparation of BOMs
- Preparation of Product drawings and tool drawings for Die-casting process and Solid 3D models in CATIA
- Preparation of protocols for initial validation of machine and process
- Implementation of ISO in the organization which includes extensive documentation works, conducting internal audits, and following ISO standards through constant monitoring of the system
- Optimizing facility layout as dictated by space constraints, new equipment installations, commissioning, and/or production expansion initiatives, in keeping with process functionality and flow
Education
Bachelor of Engineer - Mechanical Engineering
Visvesvaraya Technological University
India2008
Skills
- MS office suite
- AutoCAD/ ZWCAD, CATIA V5 and Autodesk Inventor
- Confidence and eagerness to work on new or unknown tasks
- Good communication and interpersonal skills
- Ability to learn new technologies quickly
- Good analytical abilities and decision-making skills
- Detail oriented and resourceful
- Friendly, positive attitude
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Dependable and responsible
- Computer skills
- Active listening
Languages
English
Professional Working
Hindi
Limited Working
Tamil
Native or Bilingual
Timeline
Validation Lead
Estee Lauder
03.2024 - Current
Engineering Consultant – CQV & CSV
Brevitas Consulting Inc.
08.2022 - 03.2024
Process Engineer
VPC Group
05.2019 - 03.2020
Manufacturing Specialist II (Team Lead) / Process improvement specialist
Therapure Biopharma Inc. / Resilience
05.2016 - 05.2019
Production Technician
Silfab Solar Inc.
02.2016 - 04.2016
Mechanical Engineer
BCIPL
10.2008 - 11.2014
Bachelor of Engineer - Mechanical Engineering
Visvesvaraya Technological University
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