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Validation engineer skills for your resume and career

Updated January 8, 2025

5 min read

Quoted experts

Dr. Heidrun Schmitzer,

Dr. Heidrun Schmitzer

Below we've compiled a list of the most critical validation engineer skills. We ranked the top skills for validation engineers based on the percentage of resumes they appeared on. For example, 7.4% of validation engineer resumes contained python as a skill. Continue reading to find out what skills a validation engineer needs to be successful in the workplace.

15 validation engineer skills for your resume and career

1. Python

Python is a widely-known programming language. It is an object-oriented and all-purpose, coding language that can be used for software development as well as web development.

Here's how validation engineers use python:

Developed and modified test Script & modular test suites using Python for various Mobile applications - targeting Sanity & Stability testing.
Introduced various Python object-oriented programming derivatives to develop the code with the Data Driven Testing, increased re-usability of the codes.

2. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how validation engineers use fda:

Initiated, controlled and executed validation processes and procedures for engineering as required by the FDA and other medical device regulatory systems
Conducted an in-depth quality review of critical validation packages in preparation for a regulatory FDA inspection at a vaccine facility.

3. GMP

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

Here's how validation engineers use gmp:

Prepared and reviewed installation qualification protocols for utilities; process and process support equipment for a GMP facility.
Managed overall validation responsibility and execution activities for the GMP Products at the manufacturing and the outsourcing sites.

4. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how validation engineers use medical devices:

Develop and write validation Installation/Operation Qualifications (IQ/OQ) for equipment used in manufacturing of medical devices.
Composed & executed Test Protocols & Reports for medical devices ensuring engineering requirements were met.

5. Test Results

Here's how validation engineers use test results:

Improved accuracy/integrity of scientific calculations used in final test results by incorporating in-house formulas previously calculated in Excel.
Analyze test results to ensure existing functionality performs as specified and recommended corrective actions.

6. Data Analysis

Here's how validation engineers use data analysis:

Supported product development in development of design verification testing methods, sample size selection, and data analysis.
Involve in process development/improvements, data analysis, capability study and control plan.

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7. Process Validation

Process validation refers to the accumulation and analysis of data, starting from the process design stage to production, which provides scientific evidence that the process can routinely deliver quality products. To develop an effective process validation strategy, you need to ensure that each of its three stages has been properly taken care of. The first stage is process design, where the processes are defined. The second stage is process qualification, where the process, which has been designed earlier, is evaluated to make sure it can reproduce reliable and consistent levels of quality. The final stage is continued process verification that involves ongoing validation to ensure the process is under control.

Here's how validation engineers use process validation:

Involved in development, execution, and reporting of CFR 820.75 compliant process validations and qualification protocols according to established procedures.
Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.

8. Summary Reports

Summary reports contain essential information from different operations, often organized through graphs and charts. Most summary reports are short and precise, containing highlights, conclusions, and even recommendations.

Here's how validation engineers use summary reports:

Prepare and execute installation and operational commissioning protocols as well as summary reports for Explosion Protection Systems used in dust collectors.
Prepared validation summary reports for: approval of validation protocols, solvent recovery & distillation processes, cleaning and manufacturing validations.

9. Cleaning Validation

Here's how validation engineers use cleaning validation:

Executed cleaning validation and verification protocols
Established residue limits and sample acceptance criteria, prepared comprehensive sampling plan and executed swab recovery studies to support cleaning validation.

10. IQ/OQ/PQ

Here's how validation engineers use iq/oq/pq:

Developed IQ/OQ/PQ validation protocol documents and provided technical assistance for Components, Injection Molding, Extrusion Equipment and Tooling qualifications.
Validated and defined testing parameter of equipment during Installation Qualification, Operation Qualification, and Performance Qualification (IQ/OQ/PQ).

11. Iq Oq Pq

Here's how validation engineers use iq oq pq:

Execute IQ OQ PQ protocols and work with customer validation experts.

12. Risk Assessments

The process of analyzing and identifying the acts or events that have the potential to negatively affect an individual, asset, or business is called risk assessment. Risk assessments are important because they form an integral part of an organization as well as occupational safety plans

Here's how validation engineers use risk assessments:

Performed product and process evaluation with design engineering, risk assessments, for development and manufacturing of standard calibration gas products.
Conducted validation risk assessments for software applications and equipment and made recommendations for remediation as needed.

13. ISO

Here's how validation engineers use iso:

Managed world-class engineering lab with 300+ pieces of equipment for ISO certification that enabled product validation on bench and ATE tester.
Established validation parameters for quarterly radiation audits and performed the radiation audits on product components per ISO and AAMI guidelines.

14. Computer System

Here's how validation engineers use computer system:

Provided technical, quality, and engineering support for Equipment qualification and Computer System Validation - Manufacturing systems.
Analyzed and implemented the Company's Computer Systems Validation Policy and Computer Systems Change Control Policy.

15. QA

QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.

Here's how validation engineers use qa:

Investigate Lot Deviations with a multidisciplinary team composed by Technical Services, Manufacturing and QA Departments.
Coached and collaborated with QA and Testing Team in building Use Cases, Test Cases, Test Scenarios and Test Plan.

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What skills help Validation Engineers find jobs?

Tell us what job you are looking for, we’ll show you what skills employers want.

What skills stand out on validation engineer resumes?

Dr. Heidrun Schmitzer

Professor and Chair, Xavier University

Programming languages, numerical design and simulation tools, knowledge of various measurement equipment.

What soft skills should all validation engineers possess?

Dr. Heidrun Schmitzer

Professor and Chair, Xavier University

Communication, teamwork.

What hard/technical skills are most important for validation engineers?

Dr. Heidrun Schmitzer

Professor and Chair, Xavier University

Depends on the engineering career, but in general, an ability to know how to use design software, measurement/testing, and analysis equipment, in addition to prototyping and fabrication tools

What validation engineer skills would you recommend for someone trying to advance their career?

Dr. Galen Duree

Head of the Department of Physics and Optical Engineering and Professor, Rose-Hulman Institute of Technology

It again depends on what the graduate sees as their next step - graduate school or a job with a company or lab. If the next step is graduate school, the graduate should investigate what they are interested in pursuing and then where the best school is to get the experience that the graduate thinks he or she wants.

General reading about technologies or reading available articles about subjects the graduate is interested in will help generate questions they can ask potential graduate schools. This time would also be a chance to improve areas where the graduate may feel weak while an undergraduate. Many online resources can help them brush up on week background topics. Do not worry about transfer credits because that is usually not helpful in graduate school, but improve knowledge and experience in areas where the graduate feels weak. If the graduate has identified a graduate school and program to study in, the graduate school might have some recommendations about what to review. All of this will help improve success in graduate school.

If the next step is a job with a company or lab, taking courses to improve communication will help. Many technically competent or even technically brilliant people struggle with effective communication. Techniques about writing reports, making oral presentations, or communicating technical information will help improve success. The gap year also provides time to investigate technologies that the graduate wants to be involved in and the companies or labs in those areas.

Once the graduate has identified areas of interest and companies or labs that the graduate might want to work for, they can be contacted to either answer questions or point the graduate in a direction for further investigation.

In either case, a gap year can provide a chance to refine the graduate's choice for the next steps and help them prepare other skills overlooked during the undergraduate years.

What type of skills will young validation engineers need?

John Ring

Director Engineering Outreach, Elon University

While our universities consistently educate engineering students with hard skills and strong engineering fundamentals, tomorrow's engineers need to be strong communicators, collaborators, and critical thinkers. Our professional environments are filled with data and information, and the constraint is typically how much time individuals can dedicate to solving a problem. At Elon University, we educate tomorrow's engineers to have the hard skills necessary to analyze the information and situations, apply critical thinking techniques to determine ways to solve the issue, and then concisely and efficiently communicate with colleagues as solutions are being set in motion.

Do you want to know more?

List of validation engineer skills to add to your resume

The most important skills for a validation engineer resume and required skills for a validation engineer to have include:

Python
FDA
GMP
Medical Devices
Test Results
Data Analysis
Process Validation
Summary Reports
Cleaning Validation
IQ/OQ/PQ
Iq Oq Pq
Risk Assessments
ISO
Computer System
QA
Test Cases

Test Procedures
System Validation
Laboratory Equipment
R
Process Equipment
Pharmaceutical Industry
Debugging
Gamp
CSV
Test Methods
Corrective Action
CAPA
Linux
QC
Validation Studies
Windows

Test Scripts
Minitab
FMEA
Technical Support
Management System
Autoclaves
URS
CIP
Control Systems
HVAC
PLC
Regression
DFMEA
GxP

Updated January 8, 2025

Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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