What does a Validation Engineer do?
Validation engineers are qualified engineers who manage, inspect, calibrate, test, and modify the instrumentation, equipment, mechanics, and procedures used to manufacture many products. They ensure all systems run efficiently and correctly to produce high-quality products. They test systems used to develop or manufacture products, including pharmaceuticals or automobiles. They measure, analyze, and calibrate equipment and processes to ensure they create the highest quality products.
Validation engineers perform multiple exhaustive tests. They will establish validation standards, develop testing protocols, prepare equipment, document test results, and maintain records for future reference. They often coordinate with other personnel or departments the testing impacts and compose reports, making necessary adjustments to equipment or processes. They evaluate equipment to determine if it needs to be repaired or replaced and perform preventative maintenance, maintain testing equipment, and oversee the inventory of validation supplies. Validation engineers need a bachelor's degree in math, statistics, materials science, or related fields.
- Create and manage a validation master plan for the facility.
- Develop and optimize processes required for new products and equipment.
- Identify internal expertise in all aspects of validation (cleaning, CSV, etc) across the company.
- Build and manage large software validation and engineering teams with a track record of delivering consumer grade products successfully into mass production.
- Provide strategic leadership to the company's engineering, facilities and validation organization.
- Support specific activities as assigned for development of company infrastructure.
- Assist in governance of validation processes across the sites.
- Ensure appropriate staffing of team with validation subject matter experts.
- Responsible for submitting any required report on progress of assigned tasks (weekly).
- Time management of validation testers, executing signaling system integration testing.
- Drive decisions on test strategies with collaboration between quality assurance, systems engineering and development teams.
- Train manufacturing and QC personnel on cleaning validation protocols and procedures.
- Review protocols, residue limits, reports and cleaning verification/validation summary packages.
- Ensure documentation readiness and assist with preparations for regulatory agency and client audits regarding validation activities.
- May contribute to the development of policies and procedures.
- Continually evaluate and balance short-term production support needs with long-term strategic objectives of the department.
- Support audits and inspections as an SME for validations.
- Support identification of new opportunities at assigned project /client site(s).
- Follow up with others to ensure that agreements and commitments have been fulfilled.
- Provide validation support and guidance to major capital projects and corporate initiatives.
- Plan, organize, and track assigned tasks to ensure that the schedule commitments are kept.
- Create and maintain a climate of quality and safety within the team and other departments by identifying and monitoring quality and safety standards.
- Assume responsibility for successfully accomplishing work objectives and delivering business results.
- Ensure information is complete and accurate.
- Work well with others while providing support and assistance to team members to help accomplish objectives.
- Bachelor's or Graduate's Degree in computer engineering, computer science, electrical engineering or engineering.
- Experience with C, GXP, SOC, Python, and R Language software and systems.
- Can participate in Agile ceremonies including daily scrums.
- A leader and problem solver.
- Strives for continuous improvement.
- Comfortable with calibration and risk assessments.
- Familiar with test execution and requirements management.
- Able to calibrate programming and protocols while debugging when necessary.
- Attention to detail with an eye on project closure.
How much does a Validation Engineer make?
Validation Engineer Career Path
Learn how to become a Validation Engineer, what skills and education you need to succeed, and what level of pay to expect at each step on your career path.
Average Years of Experience
Validation Engineer Insights
“Work life balance is a little difficult but there is support around you that encourages it.”
“Good work and Salary.”
“DocFox is a company that really cares about the personal and career growth of everyone.”
“This career gave me the opportunity to further explore my skills and helped me evolve as a Validation Engineer.”
“I have enjoyed the new approach with skill development and the clear communication on how to grow.”
“Individual's career path and aspirations is not a priority”
“great the pay is great”
“work and life balance is good”
Validation Engineer Interviews
Frequently asked questions about the roles and responsibilities of a Validation Engineer
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