We are looking for a Validation Engineer to ensure that products meet the standards set by the FDA and GMP guidelines. You will be responsible for writing and executing protocols, analyzing data, and reporting results to the appropriate personnel. You should have a thorough understanding of FDA, GMP, and data analysis. Your responsibilities will include gathering requirements from stakeholders, analyzing data for accuracy, drafting protocols and reports, and executing validation tests. You will also be responsible for identifying and troubleshooting problems that occur during the testing process. Additionally, you should have experience with various validation techniques and be able to compile and report validation results. Ultimately, you will help us ensure that our products meet the necessary standards and regulations.
• As a Validation Engineer at Rezi, responsible for developing and executing test plans to ensure product performance, reliability, and scalability
• Design test cases and protocols to ensure software meets functional, performance, and security criteria• Monitor, analyze, and report on software performance and reliability to ensure quality
• Collaborate with product owners, developers, and other engineers to ensure requirements are met
• Troubleshoot and root cause problems related to software design and implementation
• Create and maintain documentation of validation processes and results
• Actively participate in product design, development, and deployment process to ensure quality
• Bachelor’s degree in engineering or a related field.
• 5+ years of experience in validation engineering.
• Experience in designing and executing validation protocols, test plans, and reports.
• Proficient in utilizing risk management and FMEA for product validation.
• Knowledge of ICH, FDA and ISO standards for medical device validation.
• Strong problem-solving and analytical skills.
• Ability to prioritize tasks and manage multiple projects.
• Excellent verbal and written communication skills.
• Working knowledge of design control and software development processes.
• Proficient in using statistical software, such as Minitab or JMP.