Chintan Patel

chintanpatel0194@gmail.com
(646) 883-0818

Summary
 8+ years of diverse experience in Validation Testing, Computer System Validation (CSV) and Equipment
Qualification Validation.
 Extensive experience in Functional Testing, Integration Testing, Regression Testing, GUI Testing, Web
testing, Back-end Testing using SQL, Browser Compatibility Testing, Black Box Testing, System Testing
and Build Verification Testing.
 Proficient in manual and automated testing tools and to perform integration testing, user acceptance testing,
black box testing, functional testing, load/performance testing, security testing, back-end and regression
testing.
 Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile
model.
 Proficient in 21 CFR Part 11, 210, 211, 820, Risk Management, and cGMP, GxP, GAMP5, Data Integrity,
SDLC, Gap Analysis, Quality Assurance, Quality Management System and Medical device software in
regulated environments.
 Experienced in cross functional activities such as creating, populating, reviewing, and documenting SOPs,
Validation Plan, Risk Assessment, IQ/OQ/PQ, supplemental IQ/OQ/PQ, Traceability Matrices, Summary
Report, Discrepancy Re-port for the systems and equipment and documented according to company
procedures in compliance with FDA and associated regulations.
 Expertise in providing input on the performance and effectiveness of Quality System through Gap Analysis,
Change Management, Discrepancy, Data Integrity, documentation, training, and record management.
Documented Periodic Re-view Process, CAPA and Change Control for systems and equipment. Skilled in
HP ALM, Agile & Waterfall Methodologies, and testing.

Education: Master’s in Computer Information System, American College of Commerce and Technology, VA

Professional Experience

Amgen, Thousand Oaks, CA

Feb 2020 – Present
Automated Testing Validation Engineer
Responsibilities
 Managed projects & provided SME assessments for implementing software/firmware version upgrades &
changing user security permissions for existing systems, including maintaining/improving data integrity.
 Performed Back End Testing of the application writing SQL queries.
 Involved in different types of methodologies like V-Model, Agile and Waterfall methods to fulfill requirements
for GMP, GDP, GLP, and FDA regulations.
 Initiate document Change Notices and route for approvals in Agile or Windchill PLM.
 Managed contractors trained other Validation personnel about CSV program & worked cross-functionally
with multiple departments. Performed IT and UAT testing regularly in HP ALM.
 Conducted various types of testing: User Acceptance Testing, Smoke Testing, Black Box Testing, Load,
regression testing and Stress testing using manual and automated testing tool.
 Contributed to the review of internal and global SDLC SOPs, policies, and WIs to analyze gaps and revision
of SDLC procedures to align them with GAMP5, Annex 11, and other regulatory standards.
 Provide guidance on quality issues effecting the integrity of the data and system obtained and responded to
QA for review.
 Performed Gap Analysis, reviewing, and performing Corrective and Preventive Action (CAPA), and
suggesting Remediation Plan to mitigate non-compliance.
 Successfully defended CSV program during the site’s& received zero observations and/or
recommendations from the FDA. Performed Internal & Vendor Quality Audits to ISO 13485.
 Initiated change controls for new equipment and system changes. Performed ranking studies, cycle, and
load development studies on cGMP Autoclaves.
 Worked on cGMP, FDA’s 21 CFR part 11, audit trails, Enhanced Design Review (EDR) data integrity and
other compliance requirements.
 Led teams consisting of manufacturing engineers & technicians in carrying out compliance activities
 Authored, reviewed, and approved technical documents workflow in SharePoint following company SOP.
 Involved in writing and executing test cases and test scripts to validate functionalities of LIMS using HP
ALM.
 Created GxP’s Risk Assessment, GxP’s Relevancy Assessment, Part 11 Assessment document, and User
Risk Assessment.

Genentech Inc., Oceanside, CA

Aug 2017 - Jan 2020
Automated Testing Validation Engineer
Responsibilities
 Redlined SOPs for handling, testing, and submitting biological indicators used during qualification activities.
 Worked extensively in Agile Software Development model (Sprint, Scrum, Product Backlog, User Story).
 Gathered requirements and conducted interviews with Business Users and Project Manager to understand
the needs of the application. Used Agile/Scrum throughout the project life cycle.
 Demonstrated the advantages of using Selenium with Cucumber for automated testing.
 Developing and executing installation, operational, and performance qualification protocols (IQ/OQ/PQ) in
accordance with 21CFR 210 and 211 with an emphasis on process equipment qualification: compounding,
filling, inspection and packaging of vials, ampoules, and pre-filled syringes.
 Designed, developed, tested, debugged, and implemented new functionalities in SQL*LIMS by
coordinating with business users and client manager.
 Worked on HP QC/HP ALM, Enterprise Document Management System (EDMS), Documentum,
SharePoint, Insight Publisher (electronic submissions), LIMS, TrackWise, Compliance wire, manufacturing
software like SAP ERP, MES, Oracle and COTS application
 Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution,
and SOP development.
 Worked on GAMP, GxP's (GCP, GLP, GDP and GMP), and 21-CFR Part 11 regulation of Electronic
Records, Electronic Signatures and Audit Trails.
 Reviewed/Validated fixes, documentations (user manuals, installation instructions) for our MES against
GMPs. 
 Used Delta-V to operate process equipment.
 Developed protocols, executed, and generated final reports of IQ, OQ, PQ for manufacturing equipment’s
and utilities including but not limited to stainless steel vessels, autoclaves, refrigerators, compressed air,
nitrogen, and clean steam.
 Reviewing and approval of SLC deliverables (Project planning, Requirements Specification, Design
Documents, Test Plan, Test Cases (System, UAT, IQ/OQ/PQ, Test Summary Reports, Traceability Matrix,
Support and Deployment Plan)
 Participated in implementation of quality principles at the design and initial manufacturing stage of product
development.
 Coordinated with Business and IT compliance quality (QA) teams during the internal audit conducted for
the SharePoint Projects. Provided all required documentation and HP ALM Reports
 Drafted SOP's and trained users on these systems and the implications and impact of 21 CFR Part 11
complaint data systems on the day-to-day functions.
 Reviewed the Argus upgrade test plan and the IQ / OQ/ PQ scripts to ensure proper testing is included
and cover all the functionalities. Traced the requirements to the testing using the Traceability Matrix.
 Responsible for executing, updating, and writing verification test procedures to test hardware and software,
record software defects, record objective evidence of observed results, install and calibrate lab equipment.
 Developed Validation Test Plan using Risk Based Approach, Test Protocols, and Test Release Report like
Validation Testing Report, Installation Qualification Report, and Release Notes.
 Managed contractors trained other Validation personnel about CSV program & worked cross-functionally
with multiple departments. Performed IT and UAT testing regularly in HPALM by manual.

Pfizer Inc, San Diego, CA

Jan 2015 - Jul 2017
Validation Engineer
Responsibilities
 Designed and Implemented Pharmaceutical/Medical device regulations of FDA 21 CFR Part 11, Part 210,
Part 211 compliance strategies for LIMS.
 Created SQL queries to test centralized data warehouse applications.
 Work with product & DevOps teams to create & implement QA procedures and quality standards to support
all testing needs along with integrating automated tests into CI/ CD pipelines.
 Worked with a team to correct documents that were transferred from Agile to ADAPTIV.
 Participated in implementing 21 CFR part 11 and data integrity for validation deliverables throughout the
SDLC.
 Plan and lead validation activities for GxP computerized system software to ensure software applications
are accurate, complete and conform to user, company and regulatory requirements.
 Provide ongoing software quality engineering support throughout the software development lifecycle.
 Participated at developing and executing Test Plans for Installation/Operational/Performance Qualifications
(IQ/OQ/PQ) for LIMS application.
 Involved in Good Documentation Practices (GDP) in compliance with 21 CFR Part 11.
 Followed Computer System Validation CSV Master Plan to prepare, review and approve Validation
deliverables for both CSV IT and Laboratory systems as per GxP GLP, GCP, GMP, cGMP FDA
Assessment.
 Updated existing SOP’s, WI’s, User Manuals and templates related to the project module, method, and
process.
 Executed validation protocols for complex modules and documented results in HP ALM. Performed other
projects, duties, and responsibilities as specified by management without much supervision.
 Handled User Acceptance Testing in parallel to validation testing.
 Developed, executed, and documented Test Plans and Test Scripts to contribute to the validation of
LabWare LIMS in addition to validating LabWare LIMS to be regulatory compliant to meet 21 CFR Part 11,
FDA Regulations.
 Participated in performing Part 11 assessment, especially contributing to the components involved in
maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21
CFR Part 11 regulations.

Bayer Corporation, Berkeley, CA

Nov 2013-Mar 2015
Validation Testing Engineer
Responsibilities
 Worked on cGMP, FDA’s 21 CFR part 11, audit trails, Enhanced Design Review (EDR) data integrity and
other compliance requirements. Generate, implement, and approve IQ OQ and PQ validations and MSA
protocols.
 Used Agile PLM to manage the life cycle of all the Validation documentation. Facilitate Annual Risk Review
and Risk Benefit Analysis, update Risk Assessment and Control Table, DHF, and Change Control
documentation.
 Worked on data mapping, data modeling and used SQL queries to filter data from the database.
 Carrying out duties in compliance with all SOPs, Pharmaceutical regulations such as 21 CFR Part 11 and
FDA regulations, cGMP, GDP, GLP, GCP, ICH, and European regulations guidelines.
 Responsible for carrying out end to end validation activities for Lab Instruments (UV-Vis
Spectrophotometry, UPLC) and LIMS.
 Responsible for categorizing Data Integrity gaps into Low/Medium/High risk categories.
 Responsible for implementing remediation activities to resolve data integrity issues.
 Partner with teammates to design incisive and meaningful risk-monitoring measures used for decision
making and maintain overall data integrity.
 Responsible for preparing, maintaining, and auditing the integrity of all data to be converted into Target
system. Responsible for validation of Lab Instruments such as HPLC and LCMS.
 Responsible for providing support to validation manager in handling customer queries pertaining to
validation activities. Performed end to end validation activities for TrackWise.
 Addressed GxP GLP, GCP, GMP FDA's CFR part 211, CFR Part 210 approach to compliance issues, and
summarized the outstanding problems and issues.
 Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
 Worked on authoring, reviewing various GxP related documentation.
 Worked on execution of all cleaning development, validation and continuous monitoring and verification
activities with appropriate departments.
 Identify deviations in cleaning and follow through on corrective and preventative actions (CAPA).