Quality Assurance Validation Engineer resume example with 3+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Professional Summary
A graduate in Industrial Engineering with specialization in scheduling, logistics and supply chain management. Expertise in Job Scheduling, Production Scheduling, Six Sigma Principles, Manufacturing, Quality Control and Supply Chain Drivers. Excellent analytical skills, detail oriented, identifies opportunities and consistently achieves objectives. Focused Auditing with experience in Compliance Analysis and manufacturing validation. Insightful individual when testing systems to observe, analyze, measure and calibrate processes and equipment to drive accuracy and quality. Confident with exemplary math and auditing skills.
09/2020 to CurrentQuality Assurance Validation EngineerCatalent Pharma Solutions, Inc. | Harmans, MD,
Worked as Validation Engineer on medical device research and development project to develop and execute tests for next generation of laboratory software systems.
Create and review test protocols for verifying and validating software and system requirements
Execute, and document process validation, capability studies and process improvement studies
Worked with cross function teams for leading the team of Sr. testers for preparation of verification and validation protocols.
Created and maintained all verification and validation process documents including SOPs and desk procedures.
Demonstrated ability to collaborate with multiple R&D and other functional leaders across sites in global environment
· Developed process maps derived from the work procedure at supplier’s end to detail the process of production.
· Author validation/re-validation protocols, coordinated execution, performed, summarized qualification and validation activities for spinal implants and instruments
· As a Compliance Specialist has experience for multiple clinical trials based in US, EU, Canada
· Involved in documentation & validation of VP and plans, IQ, OQ, PQ and spreadsheet validation.
· Validated Electronic Records and Electronic Signatures in accordance with FDA guidelines.
· Developed standards, Processes and training for quality oversight of clinical trials
· Worked on GxP for Adaptiv changing the Document Rev Numbers with the most updated information for easy reference.
· Have good experience in design verification testing.; Authored protocols and reports within regulations.
· Involved in analyzing business requirements to develop VMP, Summary Report, Test Plan, Test Cases and Test Scripts.
· Created templates to line out the details in production arranging the Tool description with reference to the tool prints.
· Received the Certification for FPX Training arranging the project schedule with internal teams.
· Used FPX Formula for the assessment of project structure and alignment of operations between teams.
· Involved in all phases of the validation lifecycle to comply with FDA regulations and GAMP.
· Involved in entire software Validation Life Cycle, ensured the application follows 21 CFR part 11.
· Participated in CAPA to explain process deviations and change control processes.
· Developed, conducted and documented qualifications/ validations to ensure that the products processed are proven to be reliable, safe and effective prior to release.
· Executed protocols and tested procedures pertaining to validation activities.
· Conducted validation or qualification tests of new or existing products/software in accordance with internal protocols or external standards.
· Prepared detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications.
· Analyzed validation test data to determine if process or systems have met criteria or to identify root cause of production problems.
· Implemented new validation system requirements.
· Composed reports and made adjustments to equipment or process that require improvement. Prepared equipment and document test results and maintain records for analysis.
· Trained Manufacturing Engineers on validation concepts and regulatory requirements and expectation based on FDA guidance.
06/2015 to 07/2017Manufacturing Engineer, AuditorAmaravati Manufacturing Industries & Co | City, STATE,
Assembling parts for High quality competitive products for material-handling equipment.
Worked as a machinery expertise for design and casting of Plastic Pipe production Unit.
Lead a team of six members on a continuous improvement project using DMAIC principle and succeeded in instigating a full-time solution eradicating various manufacturing issues in the facility.
Facilitated workouts, Value stream mapping sessions and performance.
Assisted in production control and performance variation techniques.
Scheduling of all the stages of production within the given constraints.
Develop an optimized industrial process control system which helped in reduction of downtime in various instances.
Obtain hands on experience through conducting technical meetings and authoring documentation of process parameters.
Interpreting and Assessing data of the process at different stages using various data interpretation tools
Managed supplier development efforts through engineering design, technical producibility, manufacturing reviews and development of solutions.
Changed materials and finishes throughout product line to improve performance and reduce corrosion.
Calculated overall production costs by evaluating material, labor and other expenditures.
05/2014 to 08/2014Engineering InternN.T.P.C Simhadri | City, STATE,
Observed the process and acquired knowledge about the working principle and safety requirements of Sinter plant operations and Blast furnace as the first stage of training.
Obtained hands on working experience through participation in daily technical meetings and documentation of process parameters under the guidance of plant supervisors.
Prepare report on the processes involved in sinter plant and blast furnace based on the acquired knowledge and functional experience.
Education
Expected in Master of Science | Industrial EngineeringSouthern Illinois University Edwardsville, Edwardsville, ILGPA:
Expected in Bachelor of Engineering | Mechanical EngineeringVignan University, Guntur, AP, GPA:
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Resume Overview
School Attended
Southern Illinois University Edwardsville
Vignan University
Job Titles Held:
Quality Assurance Validation Engineer
Process Validation Engineer, Compliance Specialist