Description

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.

‍

Responsibilities

• As a Validation Engineer at Rezi, responsible for developing and executing test plans to ensure product performance, reliability, and scalability

• Develop automated test plans using scripting languages such as Python or JavaScript

• 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

‍

Requirements

• 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.

‍

Description

We are looking for an experienced Validation Engineer to join our team at Rezi. The Validation Engineer will be responsible for ensuring the quality and compliance of our products and services. The ideal candidate should have a strong understanding of Good Manufacturing Practices (GMP) and the Food and Drug Administration (FDA) regulations. The Validation Engineer will have to review and evaluate product data and test results to ensure compliance with regulatory standards.The Validation Engineer will also be responsible for developing and implementing protocols, plans, and procedures to ensure that all products and services meet the highest quality standards. Additionally, the candidate must be able to analyze data, troubleshoot any issues, and provide detailed reports. The successful candidate should have excellent problem-solving and technical writing skills. Ultimately, the Validation Engineer will ensure our products and services meet the required quality standards.

‍

Responsibilities

• As a Validation Engineer at Rezi, responsible for developing and executing validation plans that ensure the safety and efficacy of products

• Design and implement test plans, protocols, and reports to validate the performance of products and systems

• Develop and execute validations of products, processes, and systems, including the design and execution of validation studies

• Collect and analyze data to ensure product compliance and identify trends and opportunities for improvement

• Document results of all validation activities and ensure compliance with regulatory requirements and internal standards

• Participate in risk management activities, including failure mode and effects analysis (FMEA) and root cause analysis (RCA)

• Develop and implement process improvement plans to ensure that products and processes meet the highest standards of quality and safety

• Participate in the design of experiments, troubleshooting and process optimization efforts

‍

Requirements

• 5+ years of experience in system validation engineering

• Expertise in developing test plans, test scenarios, automation of test cases and execution of tests

• Experience with developing and executing test cases for web-based applications and/or mobile applications

• Experience with developing test cases for backend systems and databases

• Experience with modern test automation tools and technologies

• Knowledge of software development processes and test methodologies

• Ability to troubleshoot and debug complex systems

• Strong problem-solving and analytical skills

• Excellent communication and collaboration skills

• Good understanding of software development life cycle and quality assurance best practices

‍