How to become A Validation Engineer

In an age when flouting regulations can mean the immediate closure of a company, Validation Engineers test manufacturing processes and equipment to ensure their compliance with relevant specifications.

• Test Engineer
• Verification Engineer
• Automation Engineer
• Instrumentation Engineer 
• Process Engineer
• Process Validation Engineer
• Computerised System Validation (CSV) Engineer

What do Validation Engineers do?

A Validation Engineer would typically need to:

• Test and retest the systems used to manufacture products to ensure they meet company requirements
• Participate in factory and site acceptance testing for new and updated manufacturing and engineering equipment
• Study documents related to the system or subsystem to be validated and master its features
• Review machine designs from the engineering departments, including drawings, specifications, databases and engineering lists
• Understand the characteristics of the system/subsystem; measure and analyse manufacturing processes; establish performance and quality criteria
• Draw samples of raw materials, intermediate and finished products for validation testing
• Collaborate with the product team to draft a validation plan/test plan, process flow diagrams and standard operating procedures
• Create and run quality tests based on appropriate protocols and features such as sampling, testing and analytical methodologies
• Evaluate engineering systems and processes; conduct troubleshooting activities using diagnostic hardware and software
• Work with contractors, suppliers and vendors to audit, diagnose, calibrate and repair systems and machinery
• Oversee equipment decisions, such as determining which pieces need to be replaced or purchased
• Manage the equipment budget and train all relevant personnel on the new equipment, if required
• Lead validation projects according to government regulations in collaboration with engineers and technicians 
• Provide relevant support to the organisation for regulatory audits; liaise with regulators to ensure compliance with safety and quality standards; provide evidence of regulatory compliance
• Prepare and maintain the testing equipment; keep and update activity logs comprising an accurate analysis of the results 
• Create databases to track validation activities; prepare and present reports and recommendations on validation progress to management and stakeholders
• Supervise and train validation technicians; write improved testing protocols for current equipment

Validation Engineers collaborate with engineers and technicians in standard offices or a warehouse-style environment at manufacturing sites to lead, plan and execute all the plant validation activities. Travel may be necessary if they are in charge of more than one manufacturing location.

Most Validation Engineers work more than forty hours per week on a set schedule. Their workload may need them to work overtime.

Finding a new job might seem challenging. Validation Engineers can boost their job search by asking their network for referrals, contacting companies directly, using job search platforms, going to job fairs, leveraging social media, and inquiring at staffing agencies.

Validation Engineers are generally employed by:

• Biotechnology Firms
• Pharmaceutical Companies
• Medical Equipment & Device Manufacturers
• The Public Utility Industry
• The Aerospace Industry
• Computer Software Industry
• Automotive Manufacturing Industry
• Systems Implementation Organisations
• Insurance Companies
• Research Organisations
• Colleges & Universities
• Heavy Equipment Manufacturers
• Food & Beverage Producers
• Large Wholesale, Retail & Distribution Agencies
• Government Agencies
• Oil, Gas & Mining Companies
• Quality Assurance, Manufacturing, Management & Engineering Consulting Firms
• Telecommunication Companies
• Construction FirmsHospitals
• Public & Private Diagnostic Laboratories

Professional associations and organisations, such as The American Society of Mechanical Engineers, are crucial for Validation Engineers interested in pursuing professional development or connecting with like-minded professionals in their industry or occupation. Membership in one or more adds value to your resume while bolstering your credentials and qualifications.

• Inadequate ability to make independent decisions
• Health issues due to lengthy periods spent sitting at a computer or desk

Aspiring Validation Engineers can aim for entry-level positions with a BSc degree provided they have several years of experience in the field. It is pretty common for validation technicians to gain valuable hands-on experience while studying for a relevant bachelor’s or master’s degree. 

Any opportunities that help you gain mechanical knowledge and an understanding of laboratory equipment and processes will prove valuable. Students who seek entry into a pharmaceutical or health and wellness devices company will need some practical experience in biomedicine, biotechnology or neuroscience. 

Generalist engineers also acquire solid experience on a regulatory or quality management project before they choose to specialise and become a Validation Engineer. Junior validation engineer positions allow for upward mobility within a company as well. Furthermore, computer systems validation engineers who have acquired adequate experience may aspire to be promoted as Validation Engineers.

However, most entry-level Validation Engineer jobs are available to candidates with just the experience they obtain as part of their degree-based internship or co-op work placement. Look for employers who offer traineeships or project work to expand your professional network and gain a deeper insight into the career.

Read about the profession and interview/job shadow experts working in validation engineering to prove your commitment to course providers and prospective employers.

Validation Engineers usually have a bachelor’s degree in mechanical, industrial, automation, manufacturing, software or electrical engineering. If their industry requires one, employers hire candidates with a bachelor’s degree in process, petroleum, structural or chemical engineering or lab science.

An engineering degree will teach you about diverse manufacturing systems and processes, fundamentals of industrial equipment, data and statistical analysis, report writing, quality assurance management, programming and regulatory compliance. In addition, you will also acquire knowledge of test plans, protection of public health and process validations.

A master’s degree will help you stand out amongst your peers. Some education providers offer a four-year MEng degree that combines a bachelor’s degree with a masters. A BEng will take four years while an MEng will last five years. 

Take note that an associate degree may also help you obtain an entry-level job, but the chances are low. A BSc (Bachelor of Science) degree can fetch you an entry-level position, provided you have adequate work experience.

Focus on mathematics, physical sciences, computer studies and English language in high school.

Although a professional engineer license is not mandatory, it will ease your entry into the field. Typical prerequisites include completing an accredited engineering degree, a set number of supervised working hours and a test/series of exams. Contact your local engineering association for more specific details.

Certification in quality and maintenance reliability from an objective and reputed organisation can help Validation Engineers stand out in a competitive job market and carry a significant salary premium of up to 18 per cent. Additional certifications in statistical software analysis, documentation and record-keeping.

Successful certification programs protect public welfare by incorporating a Code of Ethics. A combination of education, experience, and testing is generally required to gain certification, though requirements differ from region to region.

Performance, experience, and the acquisition of professional qualifications drive the career progression of Validation Engineers who may take on managerial or leadership roles. You may begin your career in a consultant’s role and progress to Supervisor before becoming a Quality Assurance Director.

Most Validation Engineers seek to become Subject Matter Experts (SMEs). As they become more familiar with the various stages and scopes of validation engineering projects, they may become a Quality Assurance Engineer, Project Engineer or a highly-valued Specialist. 

A master’s or doctorate may help you carry out advanced research with senior engineers. It will also give you increased knowledge, lead to higher earning potential and open up opportunities for promotion. Alternately, you could choose to move into business development, sales, purchasing, manufacturing management or marketing.

Those who pursue self-employment become independent engineering or manufacturing consultants with biotechnology companies. Independent Contractors get to work on short-term remediation projects for high hourly rates. 

Candidates with an engineering degree and a professional engineer license have the best job prospects.

Continuing professional development (CPD) will help an active Validation Engineer build personal skills and proficiency through work-based learning, a professional activity, formal education, or self-directed learning. 

Certification in equipment calibration from an objective and reputed organisation can increase your chances of advancement and allow you to become an independent consultant. Invest in professional engineer licensure and a master’s or doctorate if you have not acquired them already. An accredited MEng degree will put you on the fast track to achieving chartered engineer(CEng) status with your local engineering council.

Take advantage of any internal or external training programs sponsored by your company to maintain your knowledge of validation and keep abreast of industry standards and regulation.

How Does Validation Help?

In highly regulated industries like pharmaceutical manufacturing, manufacturing processes designed to produce a product must adhere to a very high standard at all times. Validation ensures the consistent quality of items produced by providing documented evidence that change in temperatures and raw materials or gradual wear and tear on machine parts does not affect the processes or equipment used in production.

Validation Engineers closely scrutinise and document every stage of the manufacturing process. They check the process itself, the systems that run the manufacturing process and the physical equipment. They can quickly identify the main reason for and source of an issue.

Potential Pros & Cons of Freelancing vs Full-Time Employment

Freelancing Validation Engineers have more flexible work schedules and locations. They have full ownership of the business and can select their projects and clients. However, they experience inconsistent work and cash flow, which means more responsibility, effort and risk.

A full-time Validation Engineer, on the other hand, has company-sponsored health benefits, insurance, and retirement plans. They have job security with a fixed, reliable source of income and guidance from their bosses. Yet, they may experience boredom due to a lack of flexibility, ownership, and variety.

When deciding between freelancing or being a full-time employee, consider the pros and cons to see what works best for you.

Validation Engineering is a highly competitive and well-paid profession with high average salaries.

Consummate Validation Engineers minimise machine downtime, help prevent sub-standard products from entering the market, improve productivity and ensure comprehensive regulatory compliance. There is always a demand for accomplished validation engineers; you just need to find a way in.

You must document your experience properly and include specific details of the equipment you worked on, the systems you validated and the projects you contributed to.