Top 10 Validation Engineer Certifications

Certifications are important for a validation engineer in the job market because they demonstrate an individual’s knowledge and skill set. Certification programs provide validation engineers with the opportunity to gain recognition for their expertise, which can help them stand out from other applicants and increase their chances of securing a position. Additionally, certifications can provide validation engineers with access to industry best practices, resources, and networking opportunities that can help them stay current with the latest trends in the field. Finally, certifications demonstrate a commitment to professional development and can often lead to higher salaries and promotions within organizations.

The purpose of this article is to provide an overview of the most relevant certifications for Validation Engineers, and explain how they can help them advance their career.

What are Validation Engineer Certifications?

Validation engineer certification is a professional certification program that helps engineers validate the performance of systems, products and processes. The certification program focuses on developing an understanding of validation principles and techniques for engineering projects. It also provides training in risk management, quality assurance, regulatory compliance and other related topics. Validation engineer certification can help an engineer demonstrate their knowledge and skills in the area of validation engineering to employers and customers. It can also help them become more competitive in the job market by increasing their chances of being hired for positions requiring knowledge of validation engineering. Additionally, the certification can provide engineers with a greater understanding of how to effectively manage validation projects from start to finish, thus leading to better project outcomes and improved customer satisfaction.

Pro Tip: When considering validation engineer certification, make sure to research the various certifications available and identify which one best fits your specific needs. Additionally, consider the cost of obtaining the certification, as well as any continuing education requirements that may be necessary for ongoing certification.

Related: What does a Validation Engineer do?

Top 10 Validation Engineer Certifications

Here’s our list of the best certifications available to Validation Engineers today.

1. Certified Validation Professional (CVP)

Certified Validation Professional (CVP) is a certification program offered by the Association for Quality Assurance and Process Improvement (AQAP). It is designed to recognize individuals who have achieved a high level of competency in the field of validation. The CVP credential demonstrates that an individual has achieved a comprehensive understanding of the principles, practices, and procedures related to validation.

In order to become certified as a CVP, applicants must pass an exam administered by AQAP. This exam covers topics such as validation processes, risk management, regulatory compliance, documentation management, and quality assurance. The exam consists of multiple-choice questions and takes approximately two hours to complete.

To be eligible for the CVP certification program, applicants must have at least three years of professional experience in the field of validation or quality assurance. Applicants should also possess knowledge in areas such as software development life cycles, configuration management systems, and process improvement techniques.

The cost for the CVP certification program varies depending on the country where it is taken. In the United States, it typically costs around $1,000 USD. Additionally, there may be additional fees associated with taking the exam such as registration fees and travel expenses if applicable.

2. Certified Software Validation Engineer (CSVE)

Certified Software Validation Engineer (CSVE) is a professional certification that demonstrates an individual’s knowledge and expertise in software validation engineering. The CSVE certification is offered by the International Association of Software Testing (IASQ).

To become certified, applicants must pass two exams: the ISTQB Foundation Level exam and the Certified Software Validation Engineer exam. The ISTQB Foundation Level exam covers topics such as software testing principles, techniques, and tools, while the CSVE exam focuses specifically on software validation engineering topics.

The cost of the exams varies depending on location and currency exchange rates, but typically ranges from $200 to $400 USD for both exams combined. It usually takes about three months to prepare for both exams, although this can vary depending on an individual's experience level and study habits.

In order to get certified, candidates must submit their application to IASQ along with proof of passing scores for both exams. Once approved, applicants will receive their CSVE certification within four weeks of submitting their application.

3. Certified Quality Validation Engineer (CQVE)

Certified Quality Validation Engineer (CQVE) is a professional certification program designed to recognize professionals who have demonstrated the knowledge and skills necessary to develop, implement, and maintain quality validation systems in the medical device industry. The CQVE certification program is administered by the American Society for Quality (ASQ).

The CQVE certification requires candidates to pass an exam that covers topics such as: risk management, design control, process validation, statistical techniques, test method validation, and product acceptance criteria. Candidates must also demonstrate their knowledge of regulatory requirements related to quality system implementation and maintenance.

It typically takes three months to prepare for the CQVE exam. Candidates should plan on spending approximately 40 hours studying for the exam. To prepare for the exam, candidates should use ASQ’s study materials and practice exams. Additionally, it is recommended that candidates attend a review course or seminar prior to taking the exam.

The cost of taking the CQVE exam varies depending on where you take it. Generally speaking, it costs between $400-$500 USD to take the exam.

In order to become certified as a CQVE, candidates must pass the CQVE exam with a score of at least 70%. Once certified, professionals must maintain their certification by earning continuing education credits every three years.

4. Certified Process Validation Engineer (CPVE)

Certified Process Validation Engineer (CPVE) is a professional certification program offered by the American Society for Quality (ASQ). The CPVE certification is designed to recognize individuals who have demonstrated expertise in process validation. It is an internationally recognized credential that validates an individual's knowledge and experience in designing, implementing, and managing effective process validation activities.

The CPVE certification requires applicants to pass a four-hour exam consisting of multiple-choice questions. The exam covers topics such as process development, validation planning, design of experiments, process control, risk management, and statistical analysis. The exam also includes case studies to assess the applicant’s ability to apply the concepts learned in the coursework.

To be eligible for the CPVE certification, applicants must have at least five years of experience in process validation or a related field. They must also have completed at least 40 hours of formal instruction in process validation or a related field within the past five years.

The cost of obtaining the CPVE certification varies depending on where you take the exam and whether you are a member of ASQ or not. Generally speaking, it will cost around $400-$500 to take the exam without being an ASQ member and around $200-$300 if you are an ASQ member.

Overall, it should take approximately six months to obtain your CPVE certification after completing all necessary requirements such as taking the exam and submitting proof of professional experience and education.

5. ASQ Certified Quality Validation Technician (CQVT)

ASQ Certified Quality Validation Technician (CQVT) is a certification program offered by the American Society for Quality (ASQ). This certification validates the knowledge and skills of individuals who work in quality validation, which is the process of ensuring that products meet customer requirements. The CQVT certification demonstrates an individual’s ability to apply quality principles and techniques to validate products and processes.

To become certified as a CQVT, applicants must pass an exam administered by ASQ. The exam consists of 80 multiple-choice questions and has a time limit of two hours. To prepare for the exam, applicants can take advantage of ASQ’s online study materials or attend an approved training course.

The cost to take the CQVT exam is $299 USD for members of ASQ, or $399 USD for non-members. After passing the exam, applicants will receive their official CQVT certificate from ASQ within 6-8 weeks.

6. American Society for Quality (ASQ) Certified Reliability Engineer (CRE)

The American Society for Quality (ASQ) Certified Reliability Engineer (CRE) is a professional certification program that recognizes individuals who have demonstrated a high level of knowledge and expertise in reliability engineering. The CRE credential is designed to demonstrate an individual's ability to apply reliability principles and practices to improve product and system performance.

To become certified, candidates must pass the ASQ Certified Reliability Engineer exam, which consists of multiple-choice questions covering topics such as reliability analysis, prediction methods, testing strategies, failure modes, and corrective action. The exam takes approximately three hours to complete.

In order to qualify for the exam, candidates must meet certain eligibility requirements. These include having at least four years of full-time work experience in the field of reliability engineering or related disciplines; possessing a bachelor’s degree or higher from an accredited college or university; and completing at least 24 hours of approved training in reliability engineering topics.

The cost of taking the ASQ Certified Reliability Engineer exam varies depending on the country where you are located. In the United States, it costs $299 USD for members of ASQ and $399 USD for non-members.

7. International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP® 5) Certification

The International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP® 5) Certification is a globally recognized certification program that provides guidance and best practices for the implementation of automated systems in the pharmaceutical industry. The certification is designed to help organizations develop, implement, and maintain compliant automated systems that meet regulatory requirements.

The GAMP 5 certification process consists of four stages:

1. Preparation: This stage involves preparing the organization’s documentation and processes to meet GAMP 5 standards.

2. Assessment: During this stage, an independent assessor will review the organization’s documents and processes to ensure they meet GAMP 5 requirements.

3. Certification: After successful completion of the assessment, the organization will be awarded with a GAMP 5 Certificate of Compliance.

4. Maintenance: The organization must maintain its compliance with GAMP 5 standards in order to retain its certification status.

It typically takes between six months and one year to complete the GAMP 5 certification process depending on how prepared an organization is prior to starting the process. To get started, organizations should contact an accredited certifying body such as ISPE or another third-party certifying body approved by ISPE in their region. The cost of getting certified varies depending on the size and complexity of the organization's system but typically ranges from $10,000-$50,000 USD plus travel expenses for an on-site assessment if required by the certifying body.

8. ISPE Baseline Guide: Commissioning and Qualification Certification

ISPE Baseline Guide: Commissioning and Qualification (C&Q) Certification is a certification program developed by the International Society for Pharmaceutical Engineering (ISPE). It is designed to help pharmaceutical companies ensure that their facility designs, equipment, and processes meet or exceed industry standards. The certification process includes a comprehensive review of the company’s C&Q program, including its design, implementation, and maintenance.

The certification process typically takes between three to six months to complete. During this time, an ISPE-certified assessor will visit the site to review documents and interview personnel involved in the C&Q program. The assessor will then provide a report with recommendations for improvement. Once all recommendations have been addressed, the company can apply for certification.

The cost of obtaining ISPE Baseline Guide: Commissioning and Qualification Certification varies depending on the size of the facility being assessed. Generally speaking, however, it can range from several thousand dollars up to tens of thousands of dollars depending on the complexity of the assessment.

9. ISPE Good Engineering Practices Certification

ISPE Good Engineering Practices (GEP) Certification is an internationally recognized certification program that provides assurance that a facility is designed, constructed, and operated in accordance with the highest quality standards. The certification is awarded by the International Society for Pharmaceutical Engineering (ISPE), which is a non-profit organization dedicated to advancing the development and use of safe and cost-effective pharmaceutical products.

The GEP Certification process typically takes 12 months or more to complete. This includes an onsite assessment of the facility, followed by an audit of the facility’s design, construction, operation and maintenance practices. The audit report must be reviewed and approved by ISPE before certification can be granted.

To get ISPE GEP Certification, applicants must first submit an application form along with supporting documents to ISPE. After review and approval of the application, applicants will be required to pay a fee for their assessment visit. During the assessment visit, assessors will evaluate all aspects of the facility’s design, construction, operation and maintenance practices against established criteria set forth by ISPE. If all criteria are met then certification will be granted following completion of the audit report.

The cost of obtaining GEP Certification varies depending on factors such as size of facility and complexity of operations. Generally speaking, fees range from $10,000 - $50,000 USD for a single site assessment visit.

10. ISPE Good Documentation Practices Certification

ISPE Good Documentation Practices (GDP) Certification is a professional certification program designed to equip pharmaceutical and medical device professionals with the knowledge and skills necessary to ensure accurate, compliant, and consistent documentation in the industry. The program focuses on the principles of good documentation practices as outlined by ISPE's Guide to Good Documentation Practices for Pharmaceuticals and Medical Devices.

The certification consists of an online course followed by a proctored exam. The course covers topics such as document control, document review, change control, archiving, and record retention. It takes approximately 8-10 hours to complete the course and exam.

To get certified, individuals must first register for the course through ISPE's website. Once registered, they can access the online course materials and take the proctored exam at any time within one year of registering. After successfully completing the exam, individuals will receive their official certificate from ISPE confirming their certification status.

The cost of the ISPE Good Documentation Practices Certification is $395 USD for non-members or $295 USD for members of ISPE.

Do You Really Need a Validation Engineer Certificate?

The answer to this question depends on your specific career goals and the requirements of the job you are applying for. If you are looking to become a validation engineer, then yes, it is likely that having a certificate in validation engineering will be necessary. Validation engineers are responsible for verifying that new products or processes meet quality standards and safety regulations. Many employers require certification as proof that potential employees have at least a basic understanding of the principles of validation engineering.

If you already have experience working as a validation engineer, then having a certificate may not be necessary. However, if you lack experience but still want to pursue a career in this field, then obtaining certification can help demonstrate your commitment to the profession and provide proof of your knowledge base. In addition, some companies may offer additional benefits to those who have earned their certificate in validation engineering, such as higher salaries or more opportunities for advancement.

Overall, whether or not you need a validation engineer certificate will depend on your individual goals and needs. If you are just starting out in the field and do not have much experience yet, then getting certified could be beneficial in order to demonstrate your commitment and knowledge base. On the other hand, if you already have experience and would like to further expand your skillset or specialize in certain areas of validation engineering, then pursuing an advanced certification could prove beneficial as well.

Related: Validation Engineer Resume Examples

FAQs About Validation Engineer Certifications

Q1. What is a Validation Engineer Certification?

A1. A Validation Engineer Certification is an industry certification that demonstrates the knowledge and skills of individuals in the field of validation engineering. The certification focuses on understanding and applying validation principles, methodologies, and best practices to ensure that products meet quality standards.

Q2. How do I become a Certified Validation Engineer?

A2. To become a Certified Validation Engineer, you must pass a written exam administered by a recognized accreditation body such as the American Society for Quality (ASQ) or the International Society for Pharmaceutical Engineering (ISPE). You must also have at least two years of experience working in the field of validation engineering in order to be eligible for the exam.

Q3. What topics are covered in the Validation Engineer Exam?

A3. The topics covered in the Validation Engineer Exam include fundamentals of validation, risk management, design control, process validation, test methods and protocols, software validation, equipment qualification, change control procedures and regulatory requirements related to validation engineering.

Q4. How long does it take to get certified as a Validation Engineer?

A4. It typically takes around 90 days from the time you register for the exam until you receive your certification status from ASQ or ISPE - assuming you pass the exam on your first attempt! However, this timeline can vary depending on individual circumstances and how quickly you are able to complete all necessary coursework and study materials prior to taking the exam.

Q5. What are some common job roles for Certified Validation Engineers?

A5. Common job roles for Certified Validation Engineers include Quality Assurance Analyst/Manager, Process/Systems Validator/Verifier/Engineer, Project Manager/Lead, Technical Writer/Editor, Regulatory Affairs Specialist/Manager and Software Quality Assurance Analyst/Engineer