Process Engineer III, MSAT

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 www.resilience.com The Process Engineer III, MSAT independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion and commercial introduction, serving as the primary technical escalation point for complex process issues. This role coaches Process Engineer I/II staff and partners cross-functionally with Validation, PMO, Supply Chain, Operations, and Quality. Job Responsibilities Technology Transfer & Process Engineering : - Independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion, ensuring process capability at each phase gate. - Leads continuous improvement workstreams across multiple assigned processes- including changeover reduction, yield improvement, OEE improvement, maintenance reliability, and waste reduction -,applying structured problem-solving (e.g., DMAIC, RCA) to drive improvements. - Authors and independentlyapprovesURS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned process areas. - Independently manages engineering projects from initiation to completion, including project justification, resourcing, timelines, and capital planning input. - Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities,utilization, and efficiencies; manages the equipment life cycle, including obsolescence planning. Continuous Improvement & Risk Management: - Independently leadschangecontrol development and implementation, evaluating cross-functional impact and applying risk-based judgment. - Performs andmaintainsrisk management activities for assigned processes and equipment using structured risk assessment tools. - Initiates deviations and leadscomplextechnical investigations across multiple processes, defining CAPAs and assessing impact. - Leads complex technical troubleshooting across multiple assigned processes, developing systematic approaches to recurring issues. Documentation & Compliance: - Authors, reviews, and independentlyapprovescontrolled documents (SOPs, Batch Records, Rework procedures) for assigned process areas. - Authors, reviews, and independentlyapprovesvalidation and change control documents, including master plans, protocols, and summary reports. - Leads validation activities and periodic reviews- including validation requiredas a result ofchanges tovalidatedprocesses,evaluating compliance status and driving corrective actions. Training & Development: - Coaches and mentors Process Engineer I and II staff on technology transfer, GMP practices, and problem-solvingmethodology. - Independently manages external technical relationships with equipment and material suppliers, evaluating solutions and resolving issues. - Designs and delivers technical training programs for Operations, Engineering, and Maintenance. - Serves as key technical contact for regulatory inspections;participatesin annual product review and biennial critical systems review. Education & Experience Minimum Qualifications: Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, withability to independently apply controlled