Modern factories in the United States rely far less on people than they do 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.
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 look overs frequently. Deciding this is up to your expertise.
In the event there are malfunctions, you will need to decide whether or not to repair of 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.
The Best Validation Engineer Resume Samples
These are some examples of job descriptions 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 process including the creation of manufacturing processing documentation and equipment operating equipment.
- Involved in validating the application according to 21 CFR Part 11 requirements.
- Followed the SDLC process and involved in all stages of 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.
- 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.
- Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows.
- 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 risk based approach for validation, leveraging documented risk assessments.
- Responsible for preparing process validation/verification protocol and report for 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 process through incident investigation system.
- Initiate and write Protocol Deviation, determination of the cause and suggestion of the corrective action to close deviation.
- 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 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.
- Validated test equipment used by Abbott engineers; then write validation assessment document that describe the use of the equipment and the validity of the intended use.
- Discuss with the engineer the used of the equipment; then review the calibration procedure and documentation to assess if the equipment are valid for their intended use.
- Document my findings and review it with the management and engineers for final sign up.
- 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 deviation encountered during the execution and provided a possible solution and implemented and executed CAPA to mitigate the process deviations.
- 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 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.
- 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.
- 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/ SOP’s for the systems and involved in training the users on them.