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0-5 years of experience
Saved $20,000 over third party system by designing hardware and software for a custom vehicle bus emulator.
- Avoided $12,000 in capital expenditure by creating a custom, complex waveform generator system using embedded C, a microprocessor and a power op amp.
- Achieved cost avoidance of $3,000 per year, per user by implementing no cost version
- Reduced computer deployment labor costs by $2,000 per year by implementing standardized computer platform, drive imaging and cloning method.
- Specified, purchased, administered and maintained 50+ Windows XP lab computers.
0-5 years of experience
Ownership for software verification and validation on a multi-functional team developing Puritan-Bennett's line of next generation Respiratory Care Products.
- Participated in design reviews finalizing designs which clarified and defined software requirements
- Provided hands-on design, development, and execution of software test plans and test protocols in accordance with defined development procedures in preparation for product V & V
- Updated and maintained 15 breath delivery protocols including traceability to requirements specification
- Mentored and leaded other test engineers and provides technical guidance as necessary during verification and validation activities
- Developed and maintained the Verification and Validation group's project schedules and roadmap ensuring project on schedule
- Ensured adherence to product specifications, industry standards, best practices, quality & regulatory procedures, and requirements to accurately test and release quality products
0-5 years of experience
Responsible for the validation and maintenance of production equipment, virtual applications, and network devices used in the development and production of pharmaceutical products.
- Authored in depth IQ/OQ/PQ protocols for electronic and mechanical devices in order to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements
- Scheduled and maintained SQL backups, reviewed and verified security access to SQL databases, and validated data points for the plant's Facility Monitoring Service
- Responsible for the label design and database accuracy of packaging barcodes for the company and its OEMs
- Performed scheduled Periodic Reviews on mechanical and electronic laboratory and manufacturing devices to ensure that all devices operated as expected and were used in compliance with industry standards
- Created, revised, and updated control system SOPs in support of protocols, computer system changes, and departmental operations
- Performed routine system administration tasks on all process equipment systems and networks
10+ years of experience
Department lead for all validation activities including process, packaging, water, method, cleaning, and computer validations for presentation during FDA audits
- Redesigned and rewrote all procedures and documents for all validation activities, as well as performed plant wide training for both US and China plants
- Performed all pharmaceutical equipment qualification activities for an average of $3MM a year of processing, packaging equipment, and plant utility systems, including travel to international vendors and assisting our China plant
- QA lead for all new in-house product launches to ensure quality is maintained and specifications are appropriate and attainable
- Using tools such as statistical process control and design of experiments, implemented cost improvement studies across the entire plant
- Created universal packaging layouts for all nationwide plants
- Coordinated the fabrication, installation, and engineering of safety and production cost improvements on all corn chip ovens across the U.S.
- Collaborated in reviewing floor layouts of all U.S. plants in order to fit a new space saving project into product lines all over the country
0-5 years of experience
Performed independent software validation on a range of RF products For Tier-1 Automotive Corp,
including: Chrysler, General Motors and Ford. Certified the functionality of Chrysler's Wireless Control Module
(WCM) and GM RFA/TX modules
- Analyzed requirements and transferred state diagrams to software requirements for software development and test case creation
- Managed a group of up to 10 people, by delegating tasks for various software releases and overseeing the documentation of results. Was the Project Lead for the mapping of Chrysler requirements against [company name]
- Increased the results proficiency of the Chrysler Diagnostics validation tests by 15% within the first 9 months.
- Directed contractors in creating new documents for future reference and testing
- Facilitated weekly international conference calls in order to manage project progress
- Analyzed signals between RFA and TX General Motors modules with Manchester coding
- Created and maintained the CMMI process documents in the configuration management system
0-5 years of experience
Developed and updated Test Procedures specific to over the air (OTA) communication with the vehicle (ie. Crash Notification, Diagnostics checks, Theft Notification, Advanced Diagnostic Access, Mobile Applications)
- Tested OnStar Module based on engineering specifications and change requests; Automated manual test procedures, increasing automated procedures from 10% to 80% in one year
- Acted as team CAN expert and trained team members on CAN bus and vehicle communication protocols
- Debugged software and test tool errors and assisted in finding solutions to complex problems
- Created and supported an OnStar Subsystem bench, which includes the Radio System (5 modules) and OnStar
- Contributed to engineering specification development
- Technical Lead for 2-3 Subsystem Test Engineers
0-5 years of experience
Established criteria for and participated in bi-annual media fills to ensure aseptic manufacturing techniques for an injectable product in the cleanroom environments during normal production.
- Established validation parameters for quarterly radiation audits and performed the radiation audits on product components per ISO and AAMI guidelines.
- Developed a cleaning validation master plan inclusive of cleaning techniques, testing methodology, analytical techniques, acceptance criteria based on current products and batch sizing, and a comprehensive schedule to ensure complete coverage of manufacturing equipment.
- Performed annual validation activities on all autoclaves and SIP (Steam in Place) cycles for critical processing equipment.
- Wrote, performed, and reviewed validation protocols and reports (IQ/OQ/PQ).
- Provided technical assistance with regard to validation issues to the process engineering department.
0-5 years of experience
Multimedia, component, and UI validation of multiple generations of Android phones and tablets
- Hardware and software troubleshooting including flashing Firmware images
- Created new test cases. Established test case sharing on the team
- Modeled well documented bug write-ups
- Repeated winner of the "Bug of the Week" award and entered the highest quantity of bugs
0-5 years of experience
Maintained test schedules for numerous locomotive orders for validation testing.
- Provided logistical and material support for testing at the Pueblo Colorado test track and customer property.
- Supported ongoing maintenance and modification of EMD test locomotives and cars.
- Supplied 2D and 3D plans and designs to group requirements.
- Involved in facility design, budgeting and interaction with the local railroad for test facility in Alabama.
- Assisted with test budgets for new model designs and upcoming projects.
- Work group representative for new product line meetings, as well as design and support meetings.
6-10 years of experience
Created Development Test Plans for EcoWise 30 amp and 50 amp Power Saving Devices
- Created Development Test Plans for MotorWise 5 amp Motor Controller
- Performed Development and Validation testing on 30 amp and 50 amp Power Saving Devices
- Traveled to and Managed Validation Testing Lab activities in Mexico City
- Created and Managed ECN and PCN forms and processes
- Formated and reported Development Testing results and records
- Supervised on site installation and Alpha testing of product
0-5 years of experience
- Implemented a software quality assurance plan and software validation SOP for mission critical systems, such as RSLogix 5/500, PanelBuilder 32/1400e, and document control software, to comply with 21 CFR Part 11.
- Initiated, performed and executed engineering studies, design of experiments, installation qualification, operation/process qualifications, corrective action activities and software validations.
- Lead programmers in the development of training and laboratory information management systems software.
- Specified, purchased, executed and validated $100,000 in laboratory instrumentation across a 1-year period.
0-5 years of experience
Provided validation expertise in the execution and support of the Mitizak Process project.
- Created and executed IOQ Protocols for Beckman Coulter Centrifuges.
- Executed IOPQ/IOQ Protocols for Stability Chambers and Moisture Analyzers.
- Met goals for the reduced timeline for Mitizak Process (Process Development).
- Performed Temperature Mapping on Stability Chambers and Incubators using Validator 2000.
- Prepared Final Reports for Beckman Coulter Centrifuges, Incubators, and Stability Chambers.
6-10 years of experience
Team Lead for system software development/verification and validation group. Plan and allocate resources for multiple long-term medical device projects
- Developed testable system requirements. Analyzed requirements for testing purposes
- Write test plans, procedures, reports, traceability matrices, and review test results in accordance with company SOP governed by ISO 13485; Quality System Regulation 21, C.F.R. pt 820; IEC 62304
- Plan, lead, and perform formal Verification and Validation activities in support of 510(k) medical device/system FDA submission package
- Created and improved risk management/failure mode analysis
0-5 years of experience
- Helped evaluate and test TI ADSL prototype designs to save company thousands of dollars and significantly reduce time to market.
- Tested software and hardware prototypes at industry interoperability test lab and at customer sites.
- Developed and implemented effective test procedures for ADSL chipsets to ensure rigorous compliance with ITU Standards G.992.1 and G.992.2, catching deficiencies in final software and hardware prototypes before they went to production.
- Tested and ensured compatibility with competitors’ G.992.1 and G.992.2 ADSL equipment and other telephony devices and data communications and security software.
- Presented test results to management and stakeholders through written and oral communications.
- Evaluated and recommended new test methods for new features for more effective deficiencies-catching and product development.
0-5 years of experience
Designed a cleaning cart in Solid Works to aid in the disassembly of QuikScale MAb columns during cleaning.
- Researched materials and processing requirements to outline functional and design specifications for a new autoclave.
- Purchased new flow meters used to monitor product flow through QuikScale MAb columns.
- Monitored and coordinated processing of experimental resin and worked with labs to sample and track the progress.
- Completed quality risk assessments and supporting documentation for the compressed air system in Manufacturing.
0-5 years of experience
Designed and developed tests for products and systems based on engineering specifications.
- Aided product design engineers in debugging and failure analysis of products.
- Setup and configured test environment and system under test
- Preformed tests on integrated systems with customer application data.
- Aided suppler engineers with integration and testing.
- Developed test software for test data verification.
- Analyzed test result data and generated test documentation
Validation Engineer Duties and Responsibilities
While a validation engineer's day-to-day duties and responsibilities are determined by where they work, there are many core tasks associated with the role. Based on our analysis of job listings, these include:
Calibrate Manufacturing Equipment To prevent issues with quality and performance during production, validation engineers look at parameters, such as accuracy and tolerance, and compare the company's products against these measurements and industry standards. They then calibrate manufacturing equipment that does not meet or exceed the accepted levels.
Design and Perform Validation Tests Validation engineers work with management and others in production to create tests that measure the performance and quality of items the company's equipment produces. This includes designing a list of standards and metrics and choosing the software, tools, and format for such tests. They then carry out these tests to produce data to analyze.
Analyze Equipment Test Results Using data analysis techniques and software, validation engineers look at validation test results to determine the main cause of defects, safety risks, and performance problems. They also use the data to provide a risk assessment and check for adherence to government standards, such as the Food and Drug Administration (FDA) for medical equipment production.
Correct Quality Issues Correcting the issues found in the tests can include recalibrating equipment, repairing machinery, or changing the company's processes or products to meet standards and reduce risks. Validation engineers may also meet with management to develop quality or process improvement plans for the long term.
Create Reports and Documentation While developing, running, and analyzing tests or making changes, validation engineers create documentation that records all steps taken and all measurements considered for future reference. This documentation helps them later run audits, troubleshoot, and provide these materials to prove compliance when necessary.
Validation Engineer Skills and Qualifications
Successful validation engineers are skilled analysts who can develop ways to generate and inspect complex data to solve problems. In addition to a bachelor's degree and work experience as a quality tester and validator, employers look for validation engineers who possess the following:- Understanding of manufacturing processes - validation engineers understand how machinery works to produce goods such as medical equipment, vehicles, and computer hardware, understanding the steps for manufacturing these items and the industry standards they must adhere to
- Quality testing - whether designing or carrying out tests, validation engineers know what factors to observe and how to structure tests for accurate and useful results
- Data analysis - validation engineers take complex data gathered from tests and use computer software to analyze the data for trends that show quality and performance issues that need further attention
- Troubleshooting - fixing errors observed in test results requires validation engineers to look at possible causes for problems with the manufacturing equipment and determine the best solution to prevent defective goods
- Communication skills -a validation engineer's work requires strong writing skills to write test plans, record results, and create documentation; interacting with management and production workers necessitates clear and effective communication
Validation Engineer Education and Training
Most employers require validation engineers to hold a bachelor's degree in quality management, statistics, manufacturing, engineering, or a related field. Areas of study can include data analysis, statistics, quality assurance management, regulatory compliance, computer programming, technical writing, and fundamentals of manufacturing equipment. Those interested in promotion to a lead validation engineer or manager role may earn a master's degree in engineering or quality management. While many employers do not require certification, the American Society for Quality (ASQ) offers numerous quality engineering certification options.
Validation Engineer Salary and Outlook
The Bureau of Labor Statistics (BLS) places validation engineers in a broad category of engineers, listing a median annual wage of $97,250 for this category. Validation engineers in the 10th percentile make around $50,600, and those with the top pay earn over $154,700 annually. Large companies employing validation engineers often provide insurance benefits packages and paid time off for vacations, illnesses, and holidays. Employment of validation engineers is expected to grow 6 percent through 2026. This is an average rate of growth, but it is slightly slower than the 8 percent growth expected for engineers in general. Having around five years of validation work experience and experience with industry tools and applications can improve prospects.
Helpful Resources
We've collected some resources that can put you on the way to becoming a validation engineer:
Society of Quality Assurance - This organization offers students and quality assurance professionals membership opportunities with access to mentorship, webinars, training programs, and exclusive content and whitepapers.
Building Quality Management Systems: Selecting the Right Methods and Tools - New validation engineers can use this manual to learn to select appropriate testing methods and tools based on testing needs. It also helps them overcome challenges with test implementation.
American Society for Quality - Connecting quality management professionals around the world, this organization provides guidance on quality standards. It offers 18 quality certifications, provides networking opportunities, and has a comprehensive database with resources for measuring and improving quality.
The Handbook for Quality Management: A Complete Guide to Operational Excellence - Using recent standards from the American Society of Quality Management, this in-depth handbook guides quality management professionals through planning quality assessments, setting benchmarks, controlling processes, conducting audits, and analyzing results.
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