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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Summary

• Seeking a full-time/contract Position in product development, manufacturing ,industrial,R&D or maintenance engineering.. •Trained and certified in installation and commissioning of LYOPHILIZER(Freeze Dryer). •Experience in identification, assessment and mitigation of possible risk factors which may often incur losses to the organizations. •Experience in validation of materials/final parts according to customer’s requirements and supported basic capacity •Strong understanding of 21 CFR’s such as 11, 210, 211, 820 including electronic records, electronic signatures, system validation strategies and documentation •Hands on experience in Commissioning, Qualification, Validation of laboratory and analytical equipment, Validation of Process, Change controls, Quality Management System/Compliance •Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Computer System Validation (CSV), Design Qualification (DQ), Facility and Utility Qualification, Installation Qualification - IQ, Operational Qualification - OQ), Validation Master Plan (VMP), SOP's, SAT, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.

Skills
  • Quality Control and Risk Assessment
  • CAPA
  • PFMEA
  • Ability to read layout and electrical diagrams
  • Gap Analysis
  • Troubleshooting
  • Calibration, Utilities
  • Equipment Validation and Commissioning
  • Cost reduction
  • Documentation
  • GMP
Work History
05/2019 to Current
Validation Engineer The Kemtah Group Black Mountain, NC,
  • Troubleshooting the Design prototypes as well as Manufacturing prototypes(Immunoassay Instruments) in R&D Environment
  • Installing the Immunoassay machines and perform the verification tests(Subsystem Level)
  • Reviewing the installation checklists and procedures and continuously working on them to make them more user friendly
  • Review service manual documentation to ensure accuracy and current version levels
  • Provide on-site support as required to ensure quality of new instrument installation and timely resolution of escalated service events
  • As per the changes in the designs actively took part in implementing the Modifications(Hardware configuration changes)
  • Review failure trend analysis data for each product assigned
  • Identify failure trends and report them to management and manufacturer for resolution
  • Initiate complaint inquiries with manufacturer as require by divisional standard operating procedures
  • Perform in-house testing of hardware and software changes prior to distribution(Dry Run).Ensure that all supporting documentation is complete and accurate
  • Actively participate in Remediation of Legacy products(Access and DXI)
  • Play a key role in verification and validation of Legacy products and processes
  • Collaborate with VAVE team(Value Engineering ) for cost reduction of project when required
  • Work closely with SME’s of different subsystems to create a user friendly trouble shooting manual
  • Provide service support, including installation(IQ,OQ,PQ),repair, modifications and preventive maintenance for in house instrumentation
  • Document and distribute technical information regarding resolutions to field
  • Maintain and monitor modification and software upgrade status report
  • Determine appropriate preventive maintenance procedures, part kits and schedules to ensure effective on-going instrument maintenance
  • Had insight on EUMDR and FDA regulations
  • References: Joe Borden,Ross Sodahl,Pradeep Pasumarthy
12/2018 to 04/2019
Manufacturing Process Engineer Danaher Phoenix, AZ,
  • Participate in process enhancing meetings on daily basis
  • Reviews the manufacturing procedures and update the procedures after the change control is approved by quality team
  • Continuously following up with assemblers and making sure that process is going in accordance with the ManufacturingProcedure(SOP)
  • Checks the production requirement and planning the weekly activities
  • Investigating the possible risks and implementing the procedures to bring down the effect of them on product as well as associates
  • Actively participated in CAPA
  • Maintaining the DHR and DMR up to date
  • Making sure that work is evenly distributed among the associates and alarming them on regular basis regarding the importance of PPE
  • Whenever there is a change in SOP conducted meetings and making all the associates aware of the changes
07/2014 to 04/2016
Validation and Commissioning Engineer Tofflon India Pvt.Ltd City, STATE,
  • Installation and commissioning of Freeze Dryers (Lyophilizers) in various pharmaceutical Industries in INDIA
  • Experience in writing and execution of IQ, OQ and PQ protocols for GMP Utilities, Equipment and system including computerized systems
  • Prepare Protocols and reports for IQ, OQ, PQ, Traceability Matrix, Engineering Test Plans and Commissioning strategies following the GXP during the protocol execution for qualifying the system
  • Develop, Review and approve system and equipment validation documentation, facility utility systems( Cold water, steam, Pneumatics),automation systems(Automatic loading and unloading systems, Filling Lines),computerized systems and manufacturing process documentation, including equipment maintenance and calibration programs
  • Work independently in executing the validation activities in qualifying the Temperature Controlled Units such as Autoclave, Freeze Dryers and Other Manufacturing Equipment’s
  • Had experience in planning the service work in advance so the output of factory is not affected by the service work
  • Had experience working in teams and delegate work amongst them so the work can be conducted in a fast pace •Had experience in making detailed reports on all the work that’s done on each machine
  • Worked on improving the performance of the machine (Lyophilizer) •Conducted Safety Check on machines before Quality checks in front of customer
  • Trained new quality personnel, entry level engineers and operators on quality test methods and manufacturing quality checks •Servicing and Troubleshooting of Lyophilizer
  • Had experience on writing and executing Validation Protocols
  • Contact Details: Mr
  • Sam Sang (Service Manager: +91 9900171095
02/2013 to 12/2013
Design and Plant Maintenance Trainee Vizag Steel Plant. India City, STATE,
  • Worked on : •Metal Injection •Molding •Sand Casting •Shell Molding
Education
Expected in 2018
Master of Science: Mechanical Engineering
LAWRENCE TECHNOLOGICAL UNIVERSITY - Southfield, MI,
GPA:

Design of Mechanical Joints • Finite Element Analysis – I • Engineering Analysis •Transport Phenomena – II • Internal Combustion Engines • Advanced Thermodynamics • Mechanics of Composite Materials and Structures • Computational Fluid Dynamics • Applied Thermodynamics • Finite Element Analysis – II • Transport Phenomena – I

Expected in 2014
Bachelor of Technology: Mechanical Engineering
KONERU LAKSHMAIAH UNIVERSITY - GUNTUR,
GPA:
Accomplishments
  • Lawrence Technological University Vapor plant which operates at steady state using water as a working fluid.
  • August 2016 – December 2016 Koneru Laxmaiah University Banana Fiber metal matrix fiber reinforced Composite for Automobile dashboard •Created Eco-friendly Automobile Dashboard using banana fiber September 2012 – February 2013 Role in Project: •Experimented with various ratios of the composite materials for the best strength and durability for automobile •Made a CAD model of the robot •Tested and acquired best results for the physical; strength and shear stress for the element.

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Resume Overview

School Attended

  • LAWRENCE TECHNOLOGICAL UNIVERSITY
  • KONERU LAKSHMAIAH UNIVERSITY

Job Titles Held:

  • Validation Engineer
  • Manufacturing Process Engineer
  • Validation and Commissioning Engineer
  • Design and Plant Maintenance Trainee

Degrees

  • Master of Science
  • Bachelor of Technology

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