SUMMARY:

• Six years of wide - ranging experience in Computer System Validation(CSV), Quality Assurance(QA), Quality Control(QC) and technical writing in Pharmaceutical and medical device companies in accordance to 21 CFR Part 11, 21 CFR Part 820 and other GxP (GMP, GCP, GLP) regulations and Good Documentation Practices (GDP).
• Good Knowledge in developing and documenting Validation Master Plan, Validation Summary Report (VSR), Requirement Traceability Matrix (RTM), Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Diversified experience in FDA regulated environment with specialty in the area of Medical device/Software Testing and Computer System Validation (CSV).
• Experience in developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Extensive work expereicne with Process Validation, Cleaning Validation, Equipment Qualification - ASTM E2500.
• Strong experience in Test Method Validation (TMV) and Equipment Validation
• Experience in validating the equipment, packaging equipment and cleaning the equipment and experience in validating equipment driven by HMI, DCS and PLC applications.
• In-depth understanding of quality engineering disciplines, e.g. Design of Experiments (DOE), Six Sigma (DMAIC), Control Charts, Statistical Process Capability (SPC), Measurement System Analysis (MSA), Gage Capability Studies and Gage R&R Studies and Process Failure Mode Effect Analysis (pFMEA).
• Draft tool/fixtures installation qualification (TFIQ), operational qualification (OQ), performance qualification (PQ), accelerated aging (AA), design verification (DV) protocols.
• Developed protocols and reports for Packaging Characterization studies and Design Verification Plan & Report (DVP&R).
• Sound Knowledge in working with Change Control Management Systems (CCMS)
• Experience with ISO 9001, AS9100, ISO 13485, Internal Audit, TIP QA, SQL, Minitab, SAS (Data Acquisition and Data Management, Data Analysis), TrackWise.
• Good Knowledge in developing, executing and reviewing IQ/OQ/PQ test scripts, Risk Assessments, Regulatory Assessments, Gap Analysis and CAPA (Corrective Action And Preventive Action) Documents and Failure Mode Effective Analysis (FMEA)
• Experience in writing and developing Test Plans, Test Cases, Test Scripts, Test Criteria, Test Procedures, and Test Summary Reports of all the laboratory equipments
• Developed Comprehensive Test cases and Test Summary Reports.
• Participated in the preparation and revision of risk assessments using tools such as Process/Design Failure Mode and Effect Analysis (PFMEA/DFMEA).
• Good Knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC) methodologies such as Water Fall, Agile, Spiral and V model
• Solid exposure to Microsoft Office applications including and not limited to MS Visio, MS Access and MS Project
• Hands on experience with GAMP 5 Guidelines
• Experience in validating a wide variety of applications like Argus Safety, Excel spreadsheets, Track Wise and LIMS.

TECHNICAL SKILLS:

Validation Protocols: 21 CFR Part 11, cGxP(cGMP, cGCP, cGLP), validation test plan, URS, FRS, DS, IQ, OQ,PQ Protocols, Requirement Traceability Matrix(RTM), Validation Summary reports and GAP analysis.

Applications: LIMS, AERS, EDMS, CCMS (Trackwise), Empower, Instruments Alliance HPLC, Trackwise, Cleaning validation and Equipment validation.

Languages: C, SQL, PL-SQL

Tools: MS office suit word, excel, Power point, Access, MS Visio, MS Project.

PROFESSIONAL EXPERIENCE:

Confidential, New Jersey, NJ

Validation Engineer

Responsibilities:

• Prepared documented procedures of the validation life cycle to ensure compliance with FDA regulations.
• Developed TMV protocols and reports for routine methods used in the laboratory.
• Validated computer systems using cGMP, cGLP and cGCP guidelines
• Documented and reviewed Standard Operating procedures (SOP's) for the various functions of the systems.
• Involved in development and execute Test Method Validations (TMVs), develop, execute, review and approve Validation protocols (IQ, OQ, and PQ) and reports
• Used US and International regulations including relevant parts of 21 CFR 820, 210, 211, 801, EN ISO 13485, and ISO 9001.
• Performed extensive DOE using Minitab to establish using Minitab for measurement variability.
• Functional and Design Specifications were developed for lab equipment
• Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, and GMP) FDA Assessment.
• Involved in developing and filing technical documentation and tracking milestones
• Reviewed templates for validation procedures of IQ's, OQ's and PQ's project Installation Qualification (IQ), Performance Qualification (PQ), Tooling Fixture Installation Qualification (TFIQ), Enterprise Change Request (ECR), and Design of Experiments.
• Involved in equipment validation of GC, HPLC, Autoclaves, Ovens, Incubators, in compliance with FDA regulations
• Prepared, authored, and executed all deliverables for software & process validation using MiniTab for statistical analysis. Used Solid Works for creating 3-D model for Test Method Validation.
• Writing and executing protocols for their manufacturing facility. IQ, OQ, PQ, PPQ, aTMV, vTMV, pFMEA, Packaging Validation, Test Method Validation, CAPAs, Gap analysis, Risk Assessments, Remediation Plans and Software Validation.
• Wrote and implemented Test Plan, various Test Cases and Test Scripts.
• Successfully closed CSV related CAPAs in both Automation and R&D.
• Review and construct Risk Management Confirmation. Requires utilizing Surgical Technique guidelines, Design Failure Mode Effect Analysis (DFMEA), Package Insert and Label for current compliance.
• Involved in GAP analysis for the verification of user requirements documentation
• Authored and reviewed user manuals and summary reports
• Established the manufacturing procedures for the monitoring, operation, and control of the devices and equipment
• Hands on experience in DFMEA and PFMEA Analysis.
• Performed and implemented peer reviews of product documentation
• Updated support documents for utilizing the functionalities of the equipment and support.
• Documented subsequent updates to the validated functionalities in a maintenance plan

Confidential, Cambridge, MA

Validation Engineer

Responsibilities:

• Validated various Process Systems like Fermentors, Filtration and Biochemical Reactors.
• Involved in writing SOP's for all the Production, Quality Control/Assurance processes.
• Involved in collection of user requirements, functional requirements and generating Conformance Standard Documents.
• Development of cleaning cycle and set parameters using Minitab
• Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation
• Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485.
• Reviewed and approved detailed Standard Operating Procedures (SOPs) for Information Qualifications (IQs) and Operational Qualifications (OQs).
• Conducted Qualification and Validation reviews, High Level Risk Assessments, Electronic Records Electronic Signature assessments for CSV systems (21 CFR 211).
• Involved in Metrology, Calibration and Validation Pharmaceutical Instruments like HPLC, Spectrophotometer, Incubator and other Analytical Instruments
• Developed and executed validation documents (TMV, IQ, TFIQ, FAI) for Remediation project to outline Processes, Equipment and Test Methods used for Incoming, Manufacturing, and Packaging processes.
• Prepared Quality Review Reports and validated existing SOP's and Batch Reports.
• Developed the Validation Master Plan for all equipments and procedures.
• Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR, part 11.
• Perform TMV leveraging assessments by reviewing dFMEAs and previously completed
• Reviewed and approved the test plans and test cases for IQs and OQs.
• Prepared IQ, OQ and PQ are for various analytical instruments such as HPLC, Spectrophotometer and Autoclaves.
• Develop mitigation plans and assign Corrective and Preventive Actions (CAPA) activities for responsible parties to mitigate non-compliance issues relating to 21 CFR Part 11 and EU Annex 11.
• Involved in auditing the application for 21 CFR Part 11FDA 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance related to Electronic Signatures and Electronic Records for Trackwise System.
• Prepared remediation plans for the Gaps found.
• Provided input and feedback to the QA team in the execution of the test plans and test cases.
• Maintained Requirements Traceability Matrix (RTM) to track requirements
• Implemented and executed IQ, OQ and PQ validations for a new production facility.

Confidential, Boca Raton, FL

System Engineer& Verification Engineer (Equipment)

Responsibilities:

• Setup/Program and write Validation Protocols for installations and Manufacturing surgical devises.
• Program/Setup/Operate a Tornos Delta 20/4 S16 for Mass Production of Medical Devises utilizing 5s and Lean manufacturing techniques.
• Setup all protocols and validation reports for medical ISO 13485 standards.
• Work with management to setup and organize an efficient medical machine shop.
• Engaged in Quality System Improvement Process. Supported Engineering and Operation in daily activities.
• Completed ISO13485 internal auditor training and participated in the internal company audits.
• Supported Incoming with daily activities and updated the incoming inspection procedure to improve the material inspection controls.
• Trained a new Quality Engineer to quality processes such as Design Control, NCE, MRB and Quality System to support the operation.
• Performed Heat Penetrations, Empty Chamber, Leak Tests, and Dart Test on steam sterilization chambers for surgical linens and laparoscopic surgical instruments.
• Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities, special measuring and test equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling and verifying process stability/capability.
• Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
• Successfully closed CSV related CAPAs in both Automation and R&D.
• Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement.
• Also participated in audits of SOX applications, Enterprise Service Providers, and internal/external audits conducted by other BMS groups in the organization.
• Validated computerized laboratory equipment based on GAMP 4 & 5.
• Worked on Factory Acceptance Test (FAT).
• Defined and completed failure mode and effect analysis (FMEA) as per GAMP 5 guidelines for the serialization project.
• Involved in qualification of packaging lines - Liquid, Semisolid and Solid dosage products.
• Maintained Requirement Traceability Matrix (RTM) to track requirements.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part compliance and prepared Deviation Reports.
• Involved in the validation of equipment and software associated with the Process Validation for manufacture of small volume Parenteral and automated filling.
• Loaded IQ, OP, PQ, TMV documents into PDM (Product Data Management) system, (a controlled.
• Responsible for converting requirements and specifications into test plans, strategies, cases and scripts or testing applications using Waterfall & Agile SDLC.
• Short-term project to conduct gap analysis on qualification documents for legacy equipment.

Confidential, Foster City, CA

Validation Engineer

Responsibilities:

• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management.
• Verified if all validation protocols including IQ, OQ, PQ are in compliance with cGMP (21 CFR Part 211).
• Maintained the laboratory in accordance to established cGMP, GLP, & 5S industry standards, conducted monthly audits of laboratory procedures and testing/product flow processes in order to identify potential areas needing focused improvements, and participated in internal and FDA audits as required.
• Reviewed and revised Process Failure Mode Effects Analysis (PFMEA).
• Created Site Validation Master Plan (SVMP) based on Risk Assessment.
• Performed and validated Quality control, Quality Assurance processes, with expert knowledge and application of GMP’s, OSHA and FDA regulations.
• Responsible for performing quality reviews of CSV deliverables (validation strategy documents, validation protocols, traceability matrices, & summary reports) in support of a Consent Decree remediation project in a waterfall environment for a pharmaceutical manufacturer.
• Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis, evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
• Performed GAMP Categorization and 21 CFR Part 11 and Annex 11 assessment for laboratory instruments and manufacturing equipments.
• Provide computer systems validation support for electronic quality management systems, spreadsheets, databases and other systems
• Follow GMP, QSR, FDA Regulations, ISO 13485 standards.
• Utilized Documentum and created documentation in all phases of the SDLC.
• Experience in Data Migration, Periodic Review, GAP Analysis, and Risk analysis, FMEA and Remediation Process.
• Developed the Validation Plan (VP) For SAP implementation by following the corporate guidelines.
• Collected User Requirements (URS) for Trackwise by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements.
• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.

Confidential, Breinigsville, PA

Validation Engineer /Quality Engineer

Responsibilities:

• Validation of Enterprise Labware, Trackwise, SAP and Spreadsheets as per 21CFR part 11 regulations.
• Reviewed existing test scripts to familiarize with the current Business system and its operation/process.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Involved in the writing of IQ/OQ/PQ Test scripts.
• Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis, evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
• Reviewed Vendor's audit report to assure adequate Quality Management System.
• Executed scripts for the formal validation process with implementation of cGMP.
• Collecting and analyzing data from (DHF) design history files and remediating them for Gaps in User needs/validation, Design inputs/Design outputs/verification
• Ensured complete 21CFR part 11 compliance assessments for manufacturing systems
• Prepared list of documents required for the cleaning validation system based on GAMP5
• Responsible for inspecting equipment in the regulated pharmaceutical sector in accordance with GXP systems.
• Send out equipment for calibration as per ISO calibration.