Validation Engineer

Virenkumar Patel Cell: 862-***-****

***, ****** ***., *** *****, Jersey City, NJ 07306 E-

mail: ***********@*****.**.**

Professional Summary:

I am a quality industry professional experience in Commissioning,

Qualification and Validation (CQV), Quality and Manufacturing in the

pharmaceutical and bio-pharmaceutical industry. Expertise in writing and

execution of Design documents, Commissioning studies, Qualification and

Validation protocols (IQ, OQ, CD and PQ), summarize final reports with

strict adherence to FDA Standards and Regulations. Supported the

Commissioning and Qualification of the Aseptic Filling Line Facility for

the sterile injectables as well as Cleaning Validation, Autoclave study and

temperature mapping study. Skills include a thorough knowledge of

Validation activities including process, cleaning and equipment

qualification, risk assessment, good documentation practice, analytical

problem solving skills with extensive project management skills. Self-

motivated individual with excellent communication and analytical skills,

ability to work independently as well as in teams, strong researching

skills, multitasker and a quick learner.

Equipment/System Expertise:

> Vial Washer, Sterilization and Depyrogenation Tunnel, Vial Sealer/Capper,

External Vial Washer, Autoclave, Temperature Control Unit, Surge Vessels

and Control System and Peristaltic Pumps.

> Kaye Validator, Xpertlog Thermal Validation Software, TrackWise,

Documentum (EDMS), Share Point, MS Word, MS Excel, MS Visio and MS

Project.

Education:

> Master of Science in Pharmaceutical Manufacturing

Stevens Institute of Technology

> Bachelor of Science in Pharmacy

Veer Narmad South Gujarat University, INDIA

Certification:

> Validation and Regulatory Affairs

Stevens Institute of Technology

Project Summary:

A & J Consulting Engineering Services, P.C., Clifton, NJ

July 2012 - Present

Client: Ben Venue Laboratories (Boehringer Ingelheim), Bedford, OH

Validation Engineer

Goal of this project is to Commissioning and Qualification of the new

Aseptic Vial Filling Line Facility including Filling Line equipments,

supporting equipments and Environment to manufacturer sterile injectables.

> Provided technical support for Commissioning and Validation activities of

the new Aseptic Filling Line including Vial Washer, Sterilization and

Depyrogenation Tunnel, Vial Sealing, External Vial Washer and supporting

equipment for the sterile injectables.

> Supported technical writing of Functional design specification documents

as well as technical writing and field execution of Commissioning and

Validation Protocols (IOQ, CD and PQ) and final reports.

> Supported Autoclave Cycle Development, Performance Qualification and

Annual Requalification studies for the equipment loads by using Kaye

Validator.

> Technical writing and execution of the Commissioning protocol for the

portable CIP Unit for tank washing.

> Provided support for Cleaning Verification and Cleaning Validation

Studies for Parts Washer and Portable CIP unit for tank washing.

> Trained on the swab sampling and rinse sampling method for the Cleaning

Validation studies.

> Supported the Cycle Development studies for the Part Washers.

> Performed Commissioning and Qualification activities on the Sterilization

and Depyrogenation Tunnel through thermal mapping.

> Supported Qualification activities on Temperature Control Unit (TCU) for

the Formulation tanks.

> Qualified HVAC Controlled Environment including Temperature, Humidity and

Pressure Differential between rooms.

> Identified and developed operational parameters for different Aseptic

Filling Line equipment through Cycle Development Studies.

> Performed risk analysis and developed traceability matrix for equipments

including Vial Washer, Sterilization and Depyrogenation Tunnel, Vial

Sealing, External Vial Washer, Surge Vessels, Surge Vessel Control

Systems and Peristaltic Pumps.

> Coordinated and communicated validation activities with team members as

well as project manager and other affected department including

Operation, Quality, Project Planning, Validation and Engineering

departments.

> Aseptic gowning qualified to work in aseptic process area.

Merck & Co. Inc., West Point, PA Dec

2011 - July 2012

Validation Engineer

Goal of this project was to qualify the Controlled Temperature Units by

thermal mapping study on West Point, PA site and investigate temperature

alarms occurred during shipment of product.

> Provided technical support for Performance Qualification (PQ) of the

controlled temperature units (CTUs) and refrigerated trailer for the

shipping of the drug products.

> Supported technical writing for protocol, investigational study and final

report, memo.

> Performed development study for Controlled Temperature Unit to optimize

the process parameters and to qualify the equipment.

> Experienced with XpertLog thermal validation system for thermal studies

with wireless and wired data loggers.

> Evaluated raw data and prepare final report for study.

> Trained in Electronic Document Management Software (EDMS), Documentum and

TrackWise quality management software.

> Supported the investigation of temperature alarms during shipment by

using Cold Stream Cold Chain Manager (CCM) software.

> Proposed new process and developed test plans for temperature alarm

investigation and issue White Paper for justification of improvements in

part of deviation reduction plan.

> Experienced to working with share point Team site software to sharing the

project's documents.

Sanofi Pasteur, Swiftwater, PA March

2011-July 2011

Manufacturing Technician

Goal of this project was production of Flu vaccines production by following

the FDA regulations and 21 CFR part 210/211.

> Performed as upstream process production technician for Flu vaccine

production.

> Successfully performed the maintenance of equipment and increase the

production by eliminating the downtime of machine.

> Responsible for the inspection of eggs in the inspection station.

> Maintained the proper documentation for the production process.

> As a team, we were responsible for the disassembly, cleaning and assembly

of the harvester machine by following the SOPs.

> Maintained batch production record everyday basis with good documentation

practice.

> Maintained Proper cGMP working environment for the production process.

Lincoln Pharmaceuticals Pvt Ltd, Ahmadabad, INDIA June

2007-June 2008

QC Analyst

Goal of this project was to maintain the Quality of the product throughout

the production cycle as well as testing of the product for confirmation of

the quality drug product.

> Performed in process quality control of tablet by assay method,

dissolution and disintegration method, friability testing and thickness

testing and documented the result in BPR.

> Responsible to maintain the logbooks and improve the SOPs and Batch

production record.

> Worked with validation co-coordinator to assist in Qualification of

equipments.

> Properly stocked detailed observations in support of action, alerts and

Out of specification result investigations.

> Involved in the qualification, methods and process.

> Participated in the development of test methods and with the team member

to meet group goal and perform routine laboratory duties.

Research Project:

Stevens Institute of Technology (Academic), Hoboken, NJ

Aug 2010 - Dec 2010

Project Manager, Process Validation Project, "HBD Project"

Stevens Institute of Technology is an academic institute. Main goal of this

project was process validation process. Each process and equipment must be

validated as per FDA regulations.

> Successfully completed project as project manager for two different

groups including 5 individuals in each team.

> Provided management and multitasking skills through managing of the

project schedule, team, providing resources and solved the project

related issues.

> Obtained experience with technical writing and execution of Qualification

protocols (IQ, OQ, PQ) and PV protocols, cleaning validation.

> Effectively managed laboratory resources and evaluated test results for

product quality against multiple specifications.

> Performed Design of Experiment (DoE), process capability, process control

and Gage R&R (ANOVA, Nested) study for optimization of the various

process parameters.

> As a team, we prepared Gantt chart, Meeting minutes, Validation Master

Plan, SOPs, FMEA & Fishbone Diagram for risk analysis and Maintain all

the documentation in electronic document management system.

> Performed the conductivity study by Corning CD-55 Conductivity meter, for

uniform mixing of the ingredients.

> Performed the Cleaning Validation study including swab sample and rinse

sample.

> Performed the temperature mapping using the Omega Data Logger.

Research Presentation:

1 Year research work entitled "Formulation and Development of Rapidly

Disintegrating Tablet of Albendazole" presented in the 1st IAPST

international conference-2007 on "Drug delivery and drug targeting

research", Kolkata.

Contact this candidate