Job Opening: Validation Engineer III, CPV

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary & Responsibilities This position: Validation Engineer III, Performs, leads and troubleshoots the Continued Process Verification of the site. Specializing in general validation support. * Author, Review and approve documentation needed for Continued Process Verification (CPV). * Prepare documentation of activities, actions, and/or results. * Monitor records to ensure compliance with regulatory requirements. * Complete required training. * Ensure proper documentation practices during job activities. * Answer compliance and process questions from others. * Communicate policies and procedures to employees. * Gather, organize, and communicate operational information to others. * Communicate priorities and progress to team on a continuing basis. * Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. * Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. * Initiate appropriate action when process deviations occur. * Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments. * Coordinate with representatives from other departments. * Interact with other departments to ensure that product is inspected under validated conditions. * Interact with other departments to implement corrective/preventative actions. * Participate in cross-functional teams to meet strategic goals. * Review and approve OCMs, change controls, and document revisions. * Attend team meetings to discuss progress, initiatives, and/or other matters. * Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on. * Read and interpret diagrams, drawings, and other schematics. * Facilitate the execution of validation protocols for processes, equipment, packaging, and/or cleaning. * Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. * Participate in troubleshooting activities. * Lead process improvement activities and teams to meet strategic goals. * Facilitate communication between management and non-management. * Investigate deviations. * Close out deviations, CAPAs, and/or pAFCAs as needed. * Identify temporary and permanent fixes to address issues. * Interact with regulatory agency personnel during audits and inspections. * Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product. * Read technical publications and manuals and write associated procedures. * Approve new and updated SOPs. * Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift). * Assist process engineering and managers with improvement projects. * Recommend compliance resolutions to management. * Review and approve requirements, specifications, drawings, coding procedures, and guidelines. Minimum Qualifications: * Experience in validation or process engineering. * Demonstrated experience in a manufacturing or processing setting * Ability to expertly read and interpret drawings and diagrams * Strong analytical skills, with keen