Kumar Thenkondar
Montrose,CA
Summary
Adaptable professional with a quick-learning ability and a talent for adjusting to new environments. Skilled in rapidly acquiring new knowledge and applying it effectively. Driven by a passion for continuous learning and successfully navigating change.
Overview
17
17
years of professional experience
Work History
Senior Quality Engineer
Staar Surgical Co
Monrovia, CA
09.2023 - Current
- Reviewed manufacturing processes, technical documents and test results for accuracy and completeness.
- Generated engineering documentation and oversaw design projects.
- Communicated with clients and coworkers about analysis results.
- Finished projects on time and within budget.
- Provided training and guidance to staff on quality systems, tools, methods and techniques.
- Designed and executed test plans for product validation and reliability testing.
Validation Engineer III
PSC Biotech
Pomona, CA
08.2019 - 08.2025
- Created detailed reports documenting results from validations activities.
- Developed validation protocols for process equipment and systems.
- Authored and executed qualification protocols for clean utilities, HVAC, and manufacturing processes.
- Collaborated with cross-functional teams, including stakeholders, managers, consultants, vendors, engineering, facilities, manufacturing, QA, and QC, on projects.
- Support commissioning projects related to electrical utilities and nitrogen lines in the manufacturing facility.
- Operate the Kaye Validator AVS and Kaye Valprobe loggers for temperature mapping studies.
- Qualified thermal bonders, dry baths, incubators, chillers, lathes, testing material systems, thermal printers, material testing machines, force testers, and milling machines
- Prepare, update, review, and facilitate all required validation and engineering activities for the client.
- Author and execute validation protocols (EQs, IOQs, IOPQs, Addendums, TMVs, SOPs, COMs, and PVs) as assigned.
- Use MasterControl (QMS) to draft, route, track, and approve documents.
- Troubleshoot and repair validation equipment with vendors, as needed.
- Utilized Minitab for statistical analysis.
- Coordinated validation, maintenance, and repair activities on assigned projects with client personnel.
Validation Engineer
Med-Pharmex
Pomona, CA
07.2019 - 08.2019
- Calibrate, validate, maintain, and troubleshoot in-house equipment for all quality assurance activities.
- Provide technical assistance and expertise to the engineering department on day-to-day activities.
- Coordinate, schedule, and execute validation testing with affected departments and personnel.
- Train, mentor, and oversee new engineers in in-house validation testing with affected departments and personnel.
- Revise SOPs for any discrepancies, changes, and deviations.
- Author, compile, reconcile, and review validation documentation to meet FDA guidelines.
- Support the company in internal and external (FDA) audits to ensure the company is compliant with FDA regulations.
- Operate OPTO-22 SNAP PAC, GROOV, Kaye Validator 2000, Ellab Data Logger, MadgeTech UltraLow Data Loggers, Ignition SCADA Software, and Vaisala Data Logger for acquiring temperature, humidity, and pressure data for thermal validation and stability studies.
- Write reports to address Out-of-Specification (OOS) results and deviations to validation studies.
- Analyze validation test data to determine whether processes meet acceptance criteria.
- Identify and resolve deviations and out-of-specification results in a timely manner.
Lab Technician
Thermo Fisher Scientific Inc.
Canoga Park, CA
04.2015 - 02.2016
- Support the Technical Operations department in process validation and project management as a contractor.
- Responsible for reviewing and developing PQ, EQ, PSWI, and SOP for current processes and new equipment.
- Design and execute validation protocols to improve the current MOP.
- Performed research on product characteristics and implemented solutions.
- Assist with the quality and development for assay development in an HLA laboratory.
- Perform cell culture, flow cytometry, and antigen purification work by using universal precautions.
- Provide cross-functional support to other departments.
Production Associate I
Thermo Fisher Scientific Inc.
Pleasanton, CA
03.2014 - 02.2015
- Synthesize quality oligonucleotides as per customer specifications.
- Operate DNA synthesizers, HPLCs, Biomeks, Hamilton Stars, and Genevacs in an oligo lab.
- Perform troubleshooting and total preventive maintenance for manufacturing equipment.
- Work in ISO, GMP. And lean manufacturing environment.
- Gain experience in operating automated equipment, robotics, and data entry.
- Work on resolutions for internal and external audit nonconformances.
- Perform QC run by pipetting, aliquoting reagents, formulating, and running instruments.
- Maintain environmental monitoring of the manufacturing facility and lab results.
Product Development Intern
Rodan & Fields
San Francisco, CA
06.2013 - 11.2013
- Analyze a target market segment in skin tightening in cosmetics & dermatology
- Review patents, research articles, and publications that discusses new treatments, technology, and products in skin tightening
- Present and discuss relevant technical information to R&D team to pursue potential market trends
Student Research Assistant (Volunteer)
UC Riverside
Riverside, CA
09.2008 - 08.2011
- Led discussion sections, tutorials or laboratory sections.
- Compiled data from various sources for analysis.
- Scheduled and maintained regular office hours to meet with students.
Education
Master of Science - Biotechnology
San Jose State University
San Jose, CA05-2014
Bachelor of Science - Bioengineering
University of California, Riverside
Riverside, CA06-2010
Skills
- Data analysis
- Quality assurance
- Attention to detail
- Technical documentation
- Process validation
- Cross-functional teamwork
- SOP development
- Change management
- Quality documentation
- Engineering change management
- Client communication
- Quality training and coaching
Languages
English
Professional
Spanish
Elementary
References
References available upon request.
Timeline
Senior Quality Engineer
Staar Surgical Co
09.2023 - Current
Validation Engineer III
PSC Biotech
08.2019 - 08.2025
Validation Engineer
Med-Pharmex
07.2019 - 08.2019
Lab Technician
Thermo Fisher Scientific Inc.
04.2015 - 02.2016
Production Associate I
Thermo Fisher Scientific Inc.
03.2014 - 02.2015
Product Development Intern
Rodan & Fields
06.2013 - 11.2013
Student Research Assistant (Volunteer)
UC Riverside
09.2008 - 08.2011
Master of Science - Biotechnology
San Jose State University
Bachelor of Science - Bioengineering
University of California, Riverside
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