Jalpa Patel

Jersey City, NJ ***** T: 917-***-**** ac4kss@r.postjobfree.com

PROFESSIONAL EXPERIENCE

AstraZeneca, West Chester, OH June 2017 – Dec 2017

Senior Validation Engineer (Contractor through VTI Life Sciences)

Extract executed solvent flush and CIP recipes from Batch journals and Historian

Generate Trends, Alarm logs and event logs from R-TIP

Protocol execution, documenting Lab results and write discrepancies

Evaluate system alarms, faults and warning for Annual cleaning validation requalification plan

Deviations, Risk analyses and assessments for in- time closure of change control

Review and approved executed bulk cleaning requalification protocols

Redesign and rewrite all procedures and documents for validation related activities

Participate in cross-functional meetings and where required, lead/facilitate meeting.

Baxalta Social Circle, GA (now Shire) Aug 2015 – May 2017

Senior Validation Engineer (Contractor through VTI Life Sciences)

System walked down using P&IDs to identify and configure toggle paths

Dry and wet equipment module testing for automation check.

Manual recipe parameter testing of CIP skids and process vessels.

Commissioning, start-up and troubleshooting of DeltaV for CIP skid circuits, buffer and process tanks.

Execute shakedown and commissioning protocols for CIP systems, Filtration and chromatography skids.

Circuit integrity test of buffer, dilution and process vessels.

CIP skid phase, HOT RO rinse, Caustic and Acid rinse shakedowns.

Enter and follow up Biovoke issues and troubleshoot with automation team.

UCD and SCD execution of media prep and precept vessels.

PI Data extraction of executed CIP recipes for validation review.

Support Generate and maintain site cleaning validation master plan, protocols and reports

Train manufacturing associates on cleaning validation protocol and sampling.

Novo Nordisk, West Lebanon, NH Apr 2015 – Jun 2015

Validation Engineer (Contractor through NumbersOnly inc,)

Provided technical support for testing and qualification of bioreactors, fermenters, Lyophilizer, centrifuges, and UFDF skids

Write and execute IOQ, PQ protocols and reports for autoclave and depyrogenation oven using Kaye validator

Performed qualification of processing equipment and utility systems such as CIP/SIP

Review and revised standard operating procedures (SOPs) for various equipment.

Development and execution of qualification and other life cycle documents leveraged to support validation

Managed project documentation such as protocols, reports, calibration certificates, and process trends.

Perform Root Cause analysis and resolution of deviations.

Established a Validation Matrix to perform regularly scheduled Equipment validations.

Astellas Pharma Technologies, Norman, OK Nov 2014 – Apr 2015

Cleaning Validation Engineer (Contractor through NumbersOnly inc,)

Design, develop and execute cleaning cycle, development, verification and validation protocols.

Schedule protocol execution, validation activities and track project deliverables.

Coordinate work with cross functional departments such as QC, Engineering, manufacturing and QA

Sampling location, Residue acceptance limit and MACO calculation for Mirabegron and cleaning agents

Design and develop process and cleaning protocols for fluidized bed dryer and tablet press.

Author and execute DHT, CHT protocols for a Tablet film coating equipment

Created product and equipment grouping. Performed cleanability, solubility and recovery studies

Performed cleaning validation risk assessment report for Tablet vision inspection machine.

Optimization of campaign/cleaning cycle development of large scale Film coater and ultrasonic.

Author and review CIP operating SOPs for Tablet Press, Coating machine and Granulator.

Boehringer Ingelheim, Bedford, OH Jun 2013 – Sep 2014

Cleaning Validation specialist (Contractor through Hyde engineering & consulting,)

Served as a Technical Expert for the Cleaning Verification/Validation project under FDA consent decree.

Develop Cleaning cycle qualification protocols for Parts Washer, Tanks, Amicon Skid, Mixers and Manual equipment.

Optimization of load patterns to increase efficiency of cleaning procedures.

Spray ball/Wand qualification using riboflavin for Formulation and Mixing tanks.

Equipment bracketing, Identify and determining worst case product and system to clean

Support Generate a cleaning validation master plan detailing the acceptability of the cleaning procedure for the parts, equipment and the products.

Prepare and review documents to support cleaning validation activities such as SOPs, Protocols, reports, investigations and justification reports.

Perform and managed regular CIP and COP related to Tanks, Parts washers, Manual Cleaning equipment and swab/rinse sampling.

Provided support for verification and validation activities associated with equipment, reagents, facilities, and test methods, ensuring that all compliance and validation issues are addressed.

Neutrogena, Los Angeles, CA Jun 2012 – Apr 2013

Process Validation Engineer (Contractor through Pharma Bio-Serv inc,)

Preparation of pre-validation and process validation documents such as CCRs, MBRs, protocols, and reports.

Performed optimization, DOE studies, characterization, and process validation as well as process troubleshooting, process optimizations and assisting in investigations.

Oversee manufacturing of process pre-validation and validation batches of T-gel shampoo, body lotion.

Preparation and maintenance of Master Batch Records in a current state.

Performed CPV and process evaluation using statistical tools and trend analysis.

Prepared and Executed IQ, OQ, PQ Protocol and final report for processing tanks.

Troubleshooting and preparation of Corrective and Preventative Action Plans (CAPAs).

Ensuring all activities within cGMP compliance, Regulatory requirements and company policy.

Performed Risk Analysis using Six Sigma tools and Fish Bone Diagram for entire process during development

Stevens Pharmaceutical Research Center, Hoboken, NJ Jan 2011 – May 2012

Validation Engineer

Developed and Executed equipment IOQ, PQ protocols and final summary reports for incubator and refrigerator.

Calibration of Thermocouples for Temperature mapping studies of an autoclave.

Support the development of design and start up documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)

Cleanability studies using QbD and performing full factorial and partial factorial DOE studies of pharmaceutical products

Performed project using statistical analyses including Gage Linearity, Bias Study & Process Capability.

Analyzed data using Minitab 16 and Maintained notebook as per cGMP requirements.

Prepared SOPs, Validation Master Plan, and Batch Master Record

Shrey Laboratories Pvt Ltd., Ahmedabad, Gujarat Dec 2009 – Aug 2010

Computer system Validation associate

Developed and executed CSV Installation and Operational Qualification protocols for Coating machines and Clean In Place system.

Performed System Assessment Checklist for retrospective evaluations of Computer used on manufacturing to ensure that regulatory requirements were met.

Performed a Risk Assessment analysis to identify any gaps and develop a Corrective Action plan.

Developed a Change Control Request to delineate the remediation activities and requirements for the systems.

Developed and executed remediation plan to solve gaps found on the Risk Assessment Analysis.

Generation of SDLC validation documentation, including validation plans, audit plans, requirement specifications, test plans, test cases/scripts, traceability matrices and validation reports.

Collaborated with cross-functional teams to develop requirements (URS/FRS) for systems, applications and equipment.

Assisted in the management of controlled documents.

Ensured all systems and software are in compliance with GMP, GLP, GCP, QSR, 21 CFR Part 11, ICH guidelines, and GAMP guidelines.

Surmount Pharmaceuticals Pvt Ltd, Ahmedabad, Gujarat Oct 2008 – Nov 2009

Jr. Commissioning/ Qualification Engineer

Reviewed and verified the executed tests for the Control systems from the SAT and FAT to the onsite start up, debugging and Installation Qualification.

Coordinated development and validation protocol approvals and produced accurate summary reports.

Developed and executed Commissioning and IQ/OQ/PQ protocols for Clean in Place Systems, portable tanks, buffer holding tanks and buffer prep tanks at a new biotechnology manufacturing facility.

Coordinated validation activities with the validation specialist, System owners and Manufacturing Supervisors.

Prepared final Validation reports using the data gathered during the protocol execution.

Reviewed Qualification protocols for the Clean In Place Systems, Bioreactors, Tanks, Filtration Skid and chromatography Columns in Media Preparation, Cell Culture, Harvest and Purification Areas.

Conducted investigations for generated incidents.

EDUCATION

Master of Science in Pharmaceutical Manufacturing Engineering May 2012

Stevens Institute of Technology, Hoboken, NJ

Bachelor of Pharmacy Oct 2008

Nirma University, Gujarat, India

PROFESSIONAL CERTIFICATIONS

Validation and Regulatory affairs

Project engineering in pharmaceutical manufacturing

Pharmaceutical manufacturing practices

VTI module training on C/Q/V of utilities, facility, equipment and processes

SKILLS

Core Competence: Equipment qualification, Process and Cleaning validation, formulation, filling

Professional experience in preparing VMP, Validation Summary Report, Test Summary Report, and deviations, System Release Report.

Accustomed with performing Risk assessment using GAP Analysis and implementation of various COTS applications.

Strategizing Validation methodologies, Project plans and Qualification protocols (IQ/OQ/PQ).

Well versed with Quality system regulations 21 CFR Part 11, 58, 210, 211, and 820, ICH Q7, Q8, & Q9, Q10 CGMP, ISO-9001, ISO 13485, ASTM E2500, ASTM E2476

Skilled with ICH, FDA, EMA, Canadian and Asian regulations

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