Validation Engineer

About the Role: Interface with all departments to define validation project scope, responsibility, accountability, actions/functions, timelines, and goals. Work closely with Manufacturing, Quality and Regulatory to develop project processes for validation customer specific requirements, develop procedures, SOPs, protocols for project management. Develop and manage validation master list activities to support validations and qualifications as required. Prepare and perform process, method, software and product qualifications as outlined in a customer specific validation protocol. Ensures project development and validation practices meet FDA/medical regulatory requirements.

Responsibilities: Interface with all departments to define validation project scope, responsibility, accountability, actions/functions, timelines, and goals. Work closely with Manufacturing, Quality and Regulatory to develop project processes for validation customer specific requirements, develop procedures, SOPs, protocols for project management. Develop and manage validation master list activities to support validations and qualifications as required. Prepare and perform process, method, software and product qualifications as outlined in a customer specific validation protocol. Ensures project development and validation practices meet FDA/medical regulatory requirements. Creating Work Instructions in regard to validation activities. Streamline and manage validation project process steps to ensure they are clear and concise. Report internally and externally on validation status. Work with all departments to achieve validation KPI and continuous progress by meeting deadlines and exceeding customer satisfaction. Coordinate changes to validation functions within all depts and customers. Ensure Software Life Cycle, Validation Periodic Review and Validation Master plans are current and on target. Create/Write and circulate all protocols, SOPs, and Work Instructions to responsible departments (including customers & suppliers) including routing management signature of approval. Provide input and output for validation testing to support product development. During R&D activities identify validation project risks that can affect form, fit, function and regulatory requirements for design, manufacturing, and quality. Interface with quality dept to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed. Perform functions as directed to support quality management and company management team. Work with R&D as technical service in transferring projects to manufacturing and statistical analysis of part measurements for DOE. Assist in validating manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety. Provide production validation support including, but not limited to, validating manufacturing process and equipment improvements. Generate and modify manufacturing process documentation and assure that manufacturing processes and related documentation follow established policies and procedures. Generate and modify FMEA documentation to support changes affecting validated product and process. Assist with qualification and requalification of sterilization processes.

Required Skills: 2-4 years of experience in med device (ISO 13485 / CFR 820)