Validation Engineers work with Quality Engineers and Process Engineers to ensure that all manufacturing plants meet the necessary specifications. Their main focus is on ensuring compliance with regulations. They may also work with solutions engineers to ensure that all equipment is capable of meeting quality standards. The top skills for this position are compliance, quality control, quality assurance, project management, and teamwork. A minimum of a bachelor’s degree is needed for this position.
The Best Validation Engineer Resume Samples
These are some examples of accomplishments we have handpicked from real Validation Engineer resumes for your reference.
- Performed Swab sampling for production equipment and instrument for Microbial contamination and Residual contamination.
- Developed the cleaning method and analyzed the sample for TOC and Bioburden.
- Developed, improve and maintain new and existing manufacturing processes including the creation of manufacturing processing documentation and equipment operating equipment.
- Validated wireless transmission systems that adhered to FCC, IC, Bell Labs, and Motorola design guidelines; using spectrum analyzers, function generators, and electrical test equipment.
- Queried details of client service requirements to assure regulatory compliance.
- Involved in validating the application according to 21 CFR Part 11 requirements.
- Followed the SDLC process and was involved in all stages of the project to develop validation deliverables.
- Involved in writing the computer system validation Risk Assessment documents, Validation Plan, Test Summary Reports, and Validation Summary Reports.
- Created OQ/PQ Scenarios in MS Visio. These scenarios were elaborated into detailed test scripts.
- Advocated for quality control concerning the validation process; regularly visited manufacturing sites to review product manufacturing and assembly procedures against schematics and specifications.
- Analyzed User Requirements and Regulatory Requirements for the Computer Systems.
- Generated Functional Requirement Specifications (FRS) document and DS (Design Specification) Document from User Requirement Specifications (URS).
- Actively involved with the application developers in developing the high-level System Design Specifications (SDS) documents.
- Used MS Visio for pictorial representation of the Design Specifications and workflow of the process.
- Provided technical expertise to clients and partners.
- Involved in the Global Implementation and Validation of Global IT applications, CAPA, and CCM workflow.
- Reviewed and updated end-to-end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures.
- Performed regulatory and risk assessment of the computer systems.
- Authored VMP (Validation Master Plan) with a risk-based approach for validation, leveraging documented risk assessments.
- Generated, integrated, and implemented new process support for all Validation Engineers in specific areas of technical expertise.
- Responsible for preparing process validation/verification protocol and report for the tablet manufacturing process.
- Involving in technology transfer from R&D to manufacturing by validating the manufacturing process and providing the BMR for commercial production to manufacturing by change control system using Trackwise software.
- Resolving any issues associated with the process through an incident investigation system.
- Initiate and write Protocol Deviation, determination of the cause, and suggestion of the corrective action to close deviation.
- Educated Validation Engineers on new validation processes, tool support, and methodology.
- Actively involved in revalidation of engineering study and validation protocol for the new L116 100L stainless steel portable tanks which involves mock soiling of product contact surfaces, collection of rinse water samples for bioburden, BET and pH, conductivity and Oxidizables, visual inspection, collection of swab samples as per location identified in the approved protocol.
- Actively involved in baseline cleaning for the new L116 portable tanks.
- Responsible for cleaning developmental studies for CIP cleaning of stationary and portable tanks used to manufacture small volume products.
- Developed custom-designed validations to meet the needs of various experts in the organization as well as any other required parameters.
- Received outstanding quality award; effectively coordinated complex technical investigations of all kinds with team effort while taking the initiative to solve issues on behalf of the organization.
- Validated test equipment used by Abbott engineers; then write validation assessment document that describes the use of the equipment and the validity of the intended use.
- Discuss with the engineer the use of the equipment; then review the calibration procedure and documentation to assess if the equipment is valid for its intended use.
- Document my findings and review them with the management and engineers for final sign-up.
- Led the verification of a $34 million project through design, test, customer acceptance inspection, and startup.
- Achieved award for reducing the probability of scrap by 20% on a $10 million project by improving controls and defect prevention.
- Developed validation documentation as required (including User Requirements Specifications plans, protocols, procedures, traceability matrix, error/defect reports, etc.).
- Prepared and executed IQ/OQ/PQ protocol for equipment, facility, and utilities as required.
- Identified deviations encountered during the execution and provided a possible solution and implemented and executed CAPA to mitigate the process deviations.
- Opened a new market for the firm in the area of high-frequency systems by creating a division known as “Affordable Frequency Meters,” which increased sales by 45% in 1992.
- Redirected team to focus on effectiveness metrics to ensure world-class product quality standards had been met by all design stages.
- Responsible for creating all the quality documents for computer system validation, throughout the application lifecycle.
- Responsible for maintaining compliance and quality of the application during scope, design, implementation, and testing phases.
- Responsible for assessing privacy impact, Impact on Patient safety, product quality, and data integrity.
- Validated airplane flight module software.
- Advised project management on the scope and methods of software development.
- Validated a new Electro-Magnetic Compatibility Chamber which remediated a compliance risk.
- Specified, purchased, and validated Vaisala Veriteq vLog System (Data Logger) which provided greater accuracy and reporting features such as group and time interval statistics.
- Developed Operation and Administration procedure as well as Access Form.
- Validated modifications to the Siemens Building Management System and incorporated the use of Data Loggers in the Design Qualification Report.
- Delivered training to approximately 35 to 50 users on advanced concepts and techniques in electronic systems design.
- Review validation deliverables and site procedures to determine system compliance with FDA regulations and company policies and procedures.
- Develop Remediation Plans to address any gaps in system compliance with FDA regulations and company policies and procedures.
- Coordinate the timely turnaround of production documentation being issued or revised through the Validation and Engineering groups.
- Endeavored to provide quality service by assuring that all tasks were performed accurately, efficiently, and with attention to detail.
- Maintained a clean work area by regularly organizing my workstation, files drawers, antistatic container, etc.
- Facilitated Change Control processes related to application or system upgrades and bug fixes.
- Coordinated the validation activities with departments, while providing support services.
- Developed/Maintained the Requirements Traceability Matrix (RTM), involved in UAT-testing.
- Developed WI/SOPs for the systems and was involved in training the users on them.
- Performed functions to ensure that customer data was accurate and up-to-date.
How to Become a Successful Validation Engineer?
Like all branches of engineering, a high amount of education and a mix of experience will be required, however, there are more opportunities available due to the shortage of workers. Many companies will offer training and certification if you have at least some of the skills, so a bachelor’s isn’t your only educational option.
Once you are hired, how you proceed depends greatly on where you work. You may find yourself anywhere from a factory to a lab, as many different locations have high-tech equipment they need functioning at all times. Regardless, your work will always be to keep the machines in good working order.
Keeping your technology working will require you to not only go through daily checks but to develop schedules for more in-depth testing. Some technology only needs to be tested in great detail every few months, while others will need far more rigorous lookovers frequently. Deciding this is up to your expertise.
In the event there are malfunctions, you will need to decide whether or not to repair or replace the machines. This will require you to balance schedules and expenses, so you will have to be organized to make the safest and most financially responsible route to save the company time and money, which they will be thankful for.
Modern factories in the United States rely far less on people than they do on large machines to produce their goods, but they still need people to ensure those machines are tested, maintained, repaired, and replaced when necessary. A validation engineer is the one they rely on to keep production running and their machines in good working order.
Hope these samples gave you an idea of what your resume should look like and some tips on how to make sure that your resume stands out from the rest.