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Professional Summary
Professional Summary
+1 (315) 928-0898
pradeep.perftest@gmail.com
PROFESSIONAL SUMMARY:
Senior CQV Engineer in Healthcare industry in Commissioning, Qualification and Validation (CQV) for all aspects
of the equipment, utilities and manufacturing setup. Responsible for scheduling, planning and execution of
validation projects for plant utilities, facilities, and process equipment. Experienced in Qualification protocol
generation, execution, and writing final reports for various new and existing systems, equipment, and facilities.
Wrote/revised SOPs and other quality documents and perform equipment requalification based on pre-
determined intervals, recent changes and modifications made to the systems per approved change control
requests.
PROJECT SUMMARY:
Vericel, MA
Sr. Validation Specialist May 2017 – Present
Responsibilities:
Developed critical validation lifecycle documentation to support the qualification/validation of equipment,
processes and utilities (IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls,
User/Functional/Design Specifications)
Developed and executed validation protocols, coordinated system and equipment documentation
collection, and execution of protocols
Performed Temperature mapping using Kaye validator and Data loggers.
Scheduled Preventive Maintainance and Calibration for equipment.
Used Asset Mnagement systems as BM RAM (Blue Mountain) and Maximo for mainitaing and tracking
Calibration and Preventive Maintainance of equipments.
Qualified Freezers, Ovens , Incubators and Autoclaves.
Developed technical SOW documents and estimate time and resources needed for projects
Solved qualification and validation execution issues using critical analysis skills; ensures alignment with client
directives and industry guidelines on validation
Ensured validation and qualification activities of products, processes, methods, facilities, utilities and
equipment comply with internal requirements and applicable regulations and standards.
Performed validations (DQ, IQ, OQ, PQ, MSA) by creating and executing protocols.
Compiled statistical data and write narrative reports summarizing quality findings.
Applied thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project
management, and other training as appropriate.
Performed variety of CQV projects/studies in areas including Cleaning verification and Equipment
commissioning and qualification, as well as projects/studies to support manufacturing.
Planned CQV projects and track execution of CQV activities/documentation versus project timeline. Manage
and plan work of the internal and contract resources.
Performed change control assessments and write/review CQV plans, study/test protocols, and summary
reports. Managed execution of study/test protocols and review test results.
Ensured consistent coordination and implementation of changes to GMP facilities, utilities, equipment,
computerized process control and information systems, as well as controlled documents
Involved in sampling and testing of the Purified water, Compressed Air and Clean Steam Systems
Performed the Facility Performance Qualification for the Quality Control lab in accordance with monitoring
limits and current Good Manufacturing Practice (cGMP)
Collaborated closely with Engineering and Process sciences in defining the role of suppliers with the
assessment of suppliers and oversight of supplier activities and documentation related to Commissioning
activities.
1
Pradeep Kavuluri
+1 (315) 928-0898
pradeep.perftest@gmail.com
2
Pradeep Kavuluri
+1 (315) 928-0898
pradeep.perftest@gmail.com
Regularly interacted with external development partners and equipment suppliers, Quality, and IT group.
Createdequipment and process specification documentation
Conduct field inspections including piping and equipment walk downs, operational startup and
troubleshooting
Developed risk assessment, system impact assessments and validation plans
Investigated deviations and write investigation report
Reviewed, analyzed and interpret system performance data for completed qualification and prepare final
package to summarize data
Responsible for maintaining Quality System Regulations including Document Control and Record Control.
Haemonetics, CA
Validation Engineer Apr 2013 – May 2015
Responsibilities:
Created and executed validation and revalidation protocols and reports, (IQ/OQ/PQ), for the validation of
new and existing processes, equipment, systems, etc.
Performed Calibrations, PM’s,EHS as a part of Equipment Qualification.
Validated Lab Equipment and scheduled PM’s and Calibrations.
Prepared and issues work instructions/layouts related to product changes or new products, processes or
methods specifying sequence of operations and standard work for manufacturing process.
Reviewed and approved the new design and process prior to release to the production floor.
Participated in design reviews; inspection of prototypes; final sign-off on new products
Developed summary reports, following good documentation practices.
Validated the Platter fixtures which are used to test the failure of the products manufactured in the
surveillance lab and CDI 500 Blood Gas Monitor present in the Heart Lung Machine.
Authored PFMEA’s for the manufactured products.
Authored Integrated Validation Planning Requirements (IVPR for Validation Plan, SOPs, URS/FRS), Integrated
Validation Test Protocol (IVTP for IQ/OQ/PQ Protocols), TM and Summary Reports.
Analyzed test scripts to check whether all functionalities have been covered within the compliance of GMP
regulations.
Involved in Method design (re-design) and validation (re-validation).
Engineered and supported major multiple capital projects as part of continuous improvement teams
Involved in selecting best-suited process equipment for applications by meeting vendors and running trail