Validation Engineer

Sita Dahal

*******@*****.***

SUMMARY

Experience in Process Validation/Equipment Validation, Risk Management, Design of Experiments, Process Improvement and Quality Control in compliance with FDA regulations.

Extensive validating experience in FDA regulated environment with good understanding of GxP and GAMP standards under the compliance of 21 CFR Part 11, 58, 210, 211.

Experienced in performing GAP analysis for 21 CFR Part 11 and successfully implemented Remediation Plan and fixed Gaps. Familiarity with ICH Q8, Q9, Q10 and Q11 guidelines.

Hands on experience in Quality Control and Validation of Solid Oral Dosage Manufacturing Processes and equipment.

Formulated the Critical Quality Attributes and Critical Process Parameters with a focus on cost reduction.

Extensive experience with Cleaning Validation and Test Method Validation.

Experience in Packaging Process Monitoring and Validation in a drug manufacturing facility.

Statistical Data Analysis Experience using Minitab, QI Macros and Distribution Analyzer.

Hands on experience in DFMEA, PFMEA, FTA, FEA Analysis.

Applied Process engineering techniques and Continuous Improvement (CI) tools like Lean and Six Sigma to optimize Industrial Systems.

Familiarity with GAMP 5 Standards.

Excellent hands on experience and knowledge of ISPE GAMP5 and ASTM E2500leveraging for rational in ‘in-process control’.

Knowledge of Corrective and Preventive Action (CAPA) reporting, handling, and closing using Trackwise.

Expertise in Gage Reproducibility and repeatability studies.

Projects and duties completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.

Extensive experience in Process Flow Diagrams for a wide range of processes..

Conducted Supplier audits, FAIR, incoming materials characterization, FAT, SAT.

Interpretation for the percentage RSD for various blends, Main effects, Pareto charts, reproducibility and repeatability studies using R&R Gage.

Proficient with Microsoft Word, Excel, Project, Visio, and SharePoint.

Extensive knowledge about analytical laboratory procedures, experience in operating trouble shooting and supporting analytical equipment like HPLC, UV-VIS Spectrophotometers, Autoclaves, pH meters and incubators.

TECHNICAL SKILLS:

MDR, DHF, DOE, SPC, FTA and FMEA, DFMEA, PFMECA, Gap Analysis, Remediation Plans, GMP, GCP, GLP environments, Validation plans, IQ, OQ, PQ, RTM, SOP, Audit Trails, Validation Summary Report, Manufacturing Procedures, Test Procedures, TMV

SolidWorks, AutoCAD, ProE

FEA, FMEA, FTA, PFMEA, DOE, DHF, SP and SPC

21 CFR Part 11, 58, 210, 211, ICH Q 8, 9, 10 &11, GAMP 5, GxP, cGMP

PROJECT EXPERIENCE:

Pharmaceutical Company, NY Aug15 - Present

QA Validation Specialist

Responsibilities:

Wrote and executed validation protocols and summary reports for CIP, COP, and SIP (Cleaning Validation).

Review OQ and PQ protocols and summary reports.

Logged deviation and performed root cause analysis.

Support the transfer of new products and processes into manufacturing.

Medtronic, Fridley, MN Feb 14 - Jun15

Manufacturing Validation Engineer

Responsibilities:

Wrote and executed validation protocols such as Installation, Operational, and Performance Qualifications (IOPQs).

Defined and executed validation test requirements for process controls.

Authored and executed Test Method Validations (TMV).

Authored PFMEA.

Performed characterization study for all the existing processes as a part of remediation activity.

Supported design for remediation the Part Critical Requirement document and product specification.

Investigated process and quality problems and implemented corrective actions.

Designed and implemented Quality Control and Validation protocols for new and existing manufacturing processes and products.

Identified and defined project and process improvement opportunities.

Directed and coordinated activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification.

Validated the applications in accordance to FDA regulations and checked to ensure compliance with 21 CFR part 11 requirements (QSR).

Wrote, monitored, managed, and reviewed protocols, including verification and validation tests, SOP’s, BOM’s.

Supported the transfer of new products and processes into manufacturing.

Reviewed change control activities related to facility equipment, systems and utilities to ensure that all changes are properly documented and impact assessments are properly conducted.

Assessed revalidation requirements and prepared recommendations and plans for such activities.

Provided direction, input and review, and approval of Engineering studies, FAT, IQ, OQ, and PQ validation protocols.

Addressed and resolved CAPA's, and NCMR's by conducting Root Cause investigations and performing GAP analysis.

Provided leadership to support Consent Decree CAPA resolution.

Adequately resource day-to-day manufacturing activities including nonconforming reports and equipment validations.

Navigated new Quality System procedures that resulted from the Consent Decree for compliance to Design Verification and Validation procedures.

Supported the Equipment Design based on process simulation results and industry design standards and was responsible for updating and maintaining Process Flow Diagrams (PFDs).

Teva Pharmaceuticals, Phoenix, AZ Feb 11 – Feb 14

Process Validation Engineer

Responsibility:

Involved in Process/Quality Improvements in the manufacturing of Solid Oral Dose and Liquid Formulation.

Executed IQ and OQ, logged the deviations and performed Root cause Analysis of it.

Extensive experience in root cause investigations and corrective action processes during product failures and documenting clinical implications.

Performed root cause investigations, identified cost savings opportunities, and drove process efficiencies.

Responsible for providing engineering support in manufacturing processes, as well as performed root cause analysis of existing products.

Prepared validation plans, produced test plans, reviewed test scripts and requirement traceability matrices, prepared test reports for IQ/OQ and PQ final reports.

Led the Design Verification and Validation testing effort by means of reporting reviewing/approving, investigating strategy for issues, and reporting project status to upper management as needed.

Initiated a process for performing Process Qualification activities as intended by ICH Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical QualitySystem.

Developed IOV protocols for packaging facility utilizing ICH Q9 and ASTM 2500 guidelines.

Reviewed equipment Specifications, Manuals, SOP's and Commissioning/ Validation protocols.

Prepared, reviewed, and developed validation documents following the ISPE guidelines, including User Requirement, Component Criticality, Enhanced Designed, Risk Assessment and System Impact.

Involved with the risk management team in implementing a risk based validation system using GAMP 5 guidelines.

Audited test scripts, protocols and reports for technical accuracy, 21CFR Part 11, 210, and 211, and GMP / GLP compliance.

Facilitated Design Review activities of new products and worked closely with product design teams to ensure quality considerations during all stages of product development.

Responsible for preparation, review, design, execution of Commissioning, and Qualification protocols for equipment.

Conducted DOEs and created Parameter Justification Reports and advocated for Quality by Design (QbD) best practices.

Provided technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls, and preparation of regulatory filings.

Demonstrated strong project engineering and project management skills taking from concept development to commercialization stages.

Developed process performance data trending for continuous process verification and process improvement.

Supported process technology transfer, process validation, and preparation of documentation.

Participated in the preparation of regulatory filing documents and inspection readiness.

Extensive experience on Test Method Validation (TMV) for analytical, attribute, and variable measurements.

Developed case study on Reproducibility and repeatability studies on the part-to-part variation & analyst to analyst using Minitab.

Executed and developed fishbone diagrams, X-bar R, X-bar S chart, Pareto chart, Run chart, Symmetry plot, and Gage R&R using Minitab.

Helped qualify the terminals and equipment for optimal configuration using Installation Qualification (IQ) and operational Qualification (OQ).

Reviewed validation deliverables such as validation master plan, validation protocols, and validation summary report for project.

Managed system upgrades, enhancements and maintenance in cGMP environment.

Performed GAP analysis and also developed the Corresponding Remediation Plan. Led cross-functional team for new product start-ups or other process changes.

Transformed Formulation/Filling/Packaging operations using lean concepts and employee engagement to deliver reduction in accidents, reduction in deviations, increase in container volume, and increase in productivity.

Led the tech-transfer of the final product manufacturing process involving bulking, formulation, filling, lyophilization, and capping to an expansion site

Responsible for Serialization/Validation Documentation development and Execution.

Focused on protocols development, revising/updating, reviewed Test Scripts, Test Sets mapping in to HPQC and exercised within GAMP5 standards.

Completed process FMEAs in manufacturing process environments to identify all types of environmental contamination in cleanroom production environments, to reduce environmental contamination and improve overall product quality.

Eli Lilly, Indianapolis, IN

Project Engineer Dec 09 – Jan 11

Responsibilities:

Developed and updated User, Functional, and Design requirements; reviewed and updated: SOP’s, Installation, Operational and Performance Qualification protocols and reports, Infrastructure Qualification, and Computer System Validation change controls; maintained the Requirements Traceability Matrix (RTM), .

Analyzed business requirements and functional design documents to prepare Validation Plan to define objective, scope, and validation strategy of the project.

Involved in Process/Quality Improvements in the manufacturing of Solid Formulation.

Performed Analytical Test Method Validations on various procedures.

Carried out CSV for hardware and software of laboratory instruments such asHPLC, UV-Vis Spectrophotometers, Lyophilizer, Autoclaves and Incubators.

Maintained the Requirements Traceability Matrix (RTM).

Experience with utilities, cleaning validation, and general production systems used in pharmaceutical manufacturing.

Created cleaning cycle development strategies and qualifications for a variety of equipment including: process vessels, chromatography skid/column, UF/DF skid, centrifuge, CIP and glass washers.

Performed Part 11 assessments of Millipore filter integrity testers with Integritest 4.

Performed pressure hold tests, bubble point tests and diffusion tests. Performed bacterial retention tests.

Experience in qualifying Vi-Cell (cell viability counters), GE Sievers (TOC analyzers), and reviewing and approving Validation Protocols (IQ, OQ and PQ) for HVAC, UFDF, Chromatography, Fermenters, HP 1100HPLC, Agilent 1200HPLC, Homogenizers, Centrifuges, Autoclaves, Depyrogenation Ovens, ADF parts washers, Lyophilizer, Process Piping, Refrigerators, Freezers, Incubators, and Lab Information Management Systems.

Supported new product development activities: Installation and Operational Qualifications, Product Qualification (IQ/OQ, PQ and PPQ) in order to achieve manufacturing readiness.

Wrote user requirements, IOQ protocols and validation summary reports for various automation software and manufacturing equipment.

Was responsible for creation of validation, calibration and cleaning programs including change controls

Defined Computer Systems according to GAMP 5 Category descriptions to determine deliverables, performed GxP, Risk and Part 11 Assessments on computer systems.

Performed and lead remediation/validation project related to the technical writing /authoring and executing validation documentation for manufacturing and packaging equipment and systems according to the GAMP5 Validation Life Cycle.

Initiated process validation of cleaning methods.

Performed cleaning validation and cleaning validation assessments; cleaning validation gap analysis to support the New Products Development and the process validation of Consumer Pharmaceutical products.

Prepared protocols and reports of process validation, cleaning validation, equipment validation and utilities validation.

Responsible for equipment procurement, equipment and process validation

Wrote remediation plan and strategy to mitigate the gaps in cleaning validation program.

Wrote protocol, executed cleaning process/cycle development studies, analyzed data and written reports for the cleaning validation.

Ensured that protocols and cleaning work instructions are approved prior to execution.

Executed Process validation of products and monitored critical process parameters, and CIP and COP cleaning validation protocols of filing and processing equipment and monitor critical cleaning parameters.

EDUCATION:

Bachelors of Science in Chemistry, Masters in Biotechnology

ASQ Certified Six Sigma Green Belt

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