validation engineer
Resume:
Venkata Pathi Raju.B
**********.*****@*****.***
Summary:
Experience in Process Validation, Risk Management, Design of Experiments, Design Verification, Process Improvement and Quality Control in compliance with FDA regulations.
Extensive experience with Design Verification, Process Validation and Test Method Validation.
Prepared packaging validation protocols and reports to support implementation of new equipment.
Performed packaging validation testing to support new product development.
Optimized processes using Lean manufacturing and six sigma methodology, developed and implemented improvements to processes and production operations, resulting in improved productivity.
Hands on Experience in the remediation of Design History Files (DHF).
Authored and documented all the aspects of Validation Master Plan (VMP) and report.
Authored Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and Validation Summary Report (VSR).
Extensive knowledge and experience in Process Validation as per FDA regulations/QSR and cGXP (GLP/GCP/GMP) guidelines
Hands on experience in performing TMV (Attribute and Variable).
Proficient in Geometric Dimensioning & Tolerance studies (GD&T), Design of Experiments (DoE) utilizing statistical analysis.
Well versed with 21CFR Part 11, Part 820, ISO 14971 and ISO 13485 guidelines.
Performed Design Validation on package including labels and IFUs/inserts.
Updated IFU’s as an outcome of preliminary design validation related dry runs.
Standardized the label templates to ensure UDI compliance to include DI and PI in labels as per GS1 standards.
Wrote and implemented Engineering Change Notices for labeling updates using Product Lifecycle Management system packages.
Attended UDI team meetings as required and created the UDI process documentation so as to support the progress of project.
Project Experience:
Validation Engineer – Zimmer Biomet, IN
May 2017 - Present
Assisted with remediation efforts and responses to FDA.
Performed characterization studies and authored reports and validation protocols for various processes.
Experience with ISO 11607, Accelerated and real time ageing and Packaging testing including seal width, seal strength, and seal integrity testing.
Updated SOPs to comply with Chapter 2 – Manufacturing control and quality control in manufacturing sites of medical device manufacturers, etc. of the Japan GMP.
Reviewed Installation Qualifications (IQs), Performance Qualifications (PQs) for various validation projects for Compression molding and Polymer Machining.
Developed and carried out performance tests on a device to characterize and document its safety. Authored summary reports for testing activities.
Created Process Validation Plans, Process Maps, Process Requirements, PFMEA, protocols and reports for IQ, OQ, PQ, and MVP's for remediation of process and equipment.
Developed and implemented process controls for manufacturing to ensure repeatability, reliability, and quality of products and processes.
Conducted engineering studies for process characterization to establish in-process specs.
Provided product and process DFM (Design for Manufacturing) input to product development engineering to enhance manufacturability.
Executed design input, design output, product specifications, and verification/validation protocols and reports.
Reviewed and modified product design inputs for adequacy, completeness and testability to facilitate accurate and repeatable testing and demonstration of design outputs.
Executed Design Transfer activities by writing a line transfer protocol and then carried it out for multiple lines and shifts.
Developed production strategy to accommodate various line configurations during DV, PV, and PPQ. Supported NPD team through design transfer as core team member.
Ensured GMP, and GDP were utilized to ensure quality of medical device specifications.
Performed development and validation of manufacturing processes for New Product Introduction (NPI).
Responsible for Test Method Validation (TMV) and Gage Repeatability & Reproducibility (Gage R&R) studies for equipment under remediation environment.
Supported development and updating of PFMEA and related risk assessment documentation.
Led the CAPA investigations using Company's CAPA process
Working experience in FDA regulated environment and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
Reviewed/analyzed complaint data to identify issues that warrant CAPA investigation.
Created and approved NCRs and performed root cause analysis.
Reviewed NCMR and CAPA-designed and deployed systems for complaint handling and resolutions.
Assessed effectiveness using the appropriate statistical sampling methods.
Reviewed and approved Engineering Change Request (ECR) and Engineering Change Notice (ECN).
Reviewed and created Production Part Approval Process (PPAP), Control Plans, Flow Chart and Failure Mode and Effect Analysis (FMEA).
Research, formal technical report and presentation generation, and learning of GxP (including GLP, GMP, GDP).
Performed and directed source and in-process inspections.
Evaluated and sourced equipment and new technologies to aid in process optimization.
Prepared engineering specifications and drawings to document component requirements.
Engineer II - Smith and Nephew, Memphis, TN
Dec 2015– Jan 2017
Responsible for supporting and developing medical device (disposable production lines) manufacturing engineering projects, processes, test and activities for various product lines.
Developed and executed protocols for package design, packaging processes validation and package shelf life testing.
Developed packaging testing protocols to insure that the packaging performs to requirements.
Assisted development of overall technical strategy in Packaging for Operations.
Tested new packaging methods and processes using various testing apparatus in qualification of packaging changes.
Provided technical expertise to manufacturing while assisting with troubleshooting and the development of innovative solutions to production packaging issues.
Increased assembly line production by tracking product flow to help identify bottleneck, detect root cause of problems by performing Design of experiment (DOE), validation of process and equipment.
Assisted in the creation of design history files determining appropriate user needs, design inputs, verification, and validation.
Created SOP's ensuring quality control, ensued GDP/ GMP guidelines were met.
Conducted test protocol and report reviews for design validation and verification.
Generate Validation Plans, IQ protocols, IQ Reports, TMV protocols, TMV Reports and Validation Plans reports. Also create, revise and implement Change Controls, Operational Procedures, Preventive Maintenance Program and protocol deviations.
Performed FMEA; Risk and Hazard Analysis, reviews, and reports.
Led the development of risk management files activity and the files consisted of DFMEA, PFMEA, Risk management plan & report.
Updated changes to medical policies and procedures using GMP, GDP.
Set process specification ranges, designed and created fixturing, wrote protocols and performed verifications and validations.
Reviewed the Design History Files (DHF) and updated them as per the deviations found in GAP assessments.
Responsible for preliminary screening and evaluation of all customer complaints
Performed device and complaint investigations and ensured that reports are consistent with respect to the CAPA process.
Managed NCMRs (Non-Conformance Material Reports) for Capital Equipment.
Performed proper containment, disposition and investigation activities.
Managed CAPA performance metrics and analyzed trends regarding the effectiveness of the Nonconformance and CAPA processes and drove improvements.
Decreased manufacturing variability and increased process output through root cause analysis.
Reviewed product field returns to determine root cause of potential manufacturing defects then developed and implemented effective corrective actions.
Updated the design of devices to increase manufacturability and reliability.
Utilized Lean Manufacturing principles to increase productivity.
Analyzed operating data from manufacturing processes using statistical tools, both proactively (statistical quality/process control) and reactively (troubleshooting).
Selected, justified and installed new equipment and tools to improve manufacturing operation efficiency using Geometric Dimensioning and Tolerances (GD&T), Bill of Materials (BOM), Material Requirements Planning (MRP).
Quality Engineer - Phoenix Medical Systems, India
Jan 2015- Nov 2015
Involved in validation process coordination within cross functional departments such as Technical Operations, Engineering, Quality Assurance, and Regulatory affairs.
Responsible for Creation, evaluation, and validation of product and process test methods and test method validations
Wrote test methods for existing work instructions (MWI, SWI, FQA, PIP) and developed strategies to validate them.
Ensured that Qualification Protocols, and Summary Reports were consistent with Good Documentation Practices prior to and after execution.
Involved in verification of Tech Reviews, PFMEAs, Process Validation Assessment Matrix (PVAMs) and Performed gap analysis on multiple products and their Design History Files (DHF). Reviewed documentation throughout the entire design life cycle
Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives
Developed functional Test Methods for design verification, process characterization, process validation, and finished product
Planning, strategizing, and executing validation activities.
Incorporated FDA guidance and external standards into functional test methods and their validations.
Responsible for maintaining Quality System Regulations including Document Control and Record Control.
Developed documentation for all aspects of validation including risk assessments, and quality and regulatory assessments.
Worked with the SMEs, internal and external Reviewers to identify gaps and mitigate the risks.
Responsible for verification of Design History file deliverables and reviewing the deliverables. Updated the DHRs, created ECOs and updated the Part drawings by Tech Review summary minutes.
Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability.
Co-ordinated with R&D, Product Development and Operations engineering teams to change product drawings, tolerances and modify inspection-sheets and set up sheets to provide validation deliverables.
Technical Skills:
Continuous Improvement: Statistical Process Control(SPC), Design of Experiments(DOE), Six Sigma(DMAIC),5S Principle, Lean Manufacturing,, PDCA continuous improvement
Risk Management: FMEA (PFMEA, DFMEA), PHA,, Root-cause analysis, OSHA Process Safety Management (PSM), PSSR,, Non-Conformances (NCRs)
Process Control: Unit operations, Process Optimization, Standard operating procedures(SOP’s)
Software’s: MINITAB,GMP,GDP, ISO 9001,ISO9000,cGXPS,Kaizen,SPC, MS project, MS VIZIO, MS Excel and Word
Education:
Masters in Industrial Technology, University of Central Missouri, MO
Bachelors in Engineering, India
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