Engineer, Verification and Validation (V&V)
 Advanced Clinical | |
 United States, California, San Diego | |
 Jan 14, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as an Engineer, Verification and Validation (V&V) in San Diego, CA. The Engineer, Verification and Validation (V&V) role will be engaged in verifying and validating product designs according to FDA requirements and internal quality standards. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * Works closely with Systems Engineering, Project Management, Marketing, Quality and Regulatory personnel to verify and validate products. * Implement project verification and validation strategies by defining and delivering verification and validation project deliverables. * Work with project teams to create, review, and approve verification and validation deliverables. * Review use cases and requirements for products to ensure that requirements and specifications can be verified and validated, including risk mitigations, usability and regulatory requirements. * Work with product development teams to understand the product configurations being developed. * Identify the data that will be required to show objectively that all configurations of the product meet their requirements, as well as the customer needs. * Define and develop test systems in the lab. Ensure that all test systems and equipment are appropriately validated and controlled. * Perform verification and validation testing. * Review and analyze test data and record pass/fail results and conclusions. Ensure that testing and results are traced to requirements. * Track and report on progress toward completion of verification and validation. * Summarize the verification and validation performed, the data reviewed, and conclusions reached. * Project deliverables may including producing and/or reviewing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations. * Manage timeline for verification and validation activities and provide updates to project teams. * Support systems engineering teams in the completion of development testing, to characterize designs and understand trade-offs. EXPERIENCE Minimum of 5 years of experience in verification or validation with at least one year of experience in product development of GMP EDUCATION Bachelors Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent To be a best-fit your strengths must include: * Experience executing verification and validation plans, and protocols. * Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools. * Understand good engineering practices and test methodologies. * Demonstrated capability to solve technical and scientific problems. * Medical equipment or other equipment experience involving complex, multi-component systems, including lab automation. * Familiar with engineering process improvement methodologies * Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities * Excellent communication and interpersonal skills About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |