Professional Summary

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. Excellent experience in Temperature Mapping.
PROJECT SUMMARY:
Vericel, MA
Sr. Validation Specialist May 2019 – 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 Maintenance and Calibration for equipment.
 Used Asset Management systems as BM RAM (Blue Mountain) and Maximo for maintaining and tracking
Calibration and Preventive Maintenance 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.
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 Performed CIP and SIP studies.
 Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects using
HPALM.
 Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are created by the
application and constantly redesigned the system to increase its user friendliness for the clients.
 Performed GAP Analysis and developed the corresponding Remediation plan.
 Authored various Validation Deliverables like Test Plan, Test Summary report and Final Validation Report
maintaining company standards.
 Designed engineering studies for new equipment.
 Executed Engineering Studies and writing Final Reports for Engineering Studies
 Performed all phases of end-to-end testing like User Acceptance Testing, Functionality Testing, Regression
Testing, GUI Testing, Negative Testing, System Testing
 Developed and Maintained the Requirement Traceability Matrix (RTM) to check the system fulfil all
requirements.
Edwards Life Sciences, CA

Validation Engineer Jun 2017 – Apr 2019
Responsibilities:
 Created and executed commissioning and qualification protocols/test plans for facilities, utilities and
equipment using a risk-based approach.
 Implemented and coordinated commissioning and qualification of manufacturing equipment and computer
systems for use in regulated and non-regulated operations.
 Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOPs, and Engineering Change Requests
 Prepared IQ, OQ, and PQ protocols for new or modified manufacturing equipment, processes, systems,
facilities, and Utilities.
 Performed temperature mapping studies and calibrations using Data loggers.
 Worked with external vendors on calibrating some critical parameters and managing certifications.
 Drafted SOP’s for Preventive maintenance techniques for various equipment.
 Performed Investigations and Root Cause Analysis and troubleshoots for various equipment and process
related issues.
 Hands on Windchill Asset Management system for maintaining Equipment Calibration Records.
 Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and
Preventive Action (CAPA), STAT testing and drafting Remediation Plans for the project management
approval after the GAP Analysis.
 Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional
Requirements Specifications (FRS)
 Authored and reviewed cleaning validation protocols and reports. Developed Cleaning validation Matrix
with worst case cleaning techniques.
 Authored commissioning and qualification of CSV documents through system life cycle. This includes
deliverables such as user requirements, functional/design specifications, qualification protocols, reporting,
and support documentation.
 Reviewed laboratory requirements and define procedures for instrument and data management/data
integrity.
 Implemented 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap
assessments and define resolutions in compliance with cGMP requirements.
 Supported installation activities when needed to ensure proper systems startup and recommend changes to
improve system design.
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 Regularly interacted with external development partners and equipment suppliers, Quality, and IT group.
 Created equipment 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 2014 – May 2017
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.
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PROFESSIONAL SUMMARY:

Edwards Life Sciences, CA

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