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 independently  approves  URS, 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 leads  change  control development and implementation, evaluating cross-functional impact and applying risk-based judgment.   Performs and  maintains  risk management activities for assigned processes and equipment using structured risk assessment tools.   Initiates deviations and leads  complex  technical 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 independently  approves  controlled documents (SOPs, Batch Records, Rework procedures) for assigned process areas.   Authors, reviews, and independently  approves  validation and change control documents, including master plans, protocols, and summary reports.   Leads validation activities and periodic reviews  — including validation required  as a result of  changes to  validated  processes ,  evaluating compliance status and driving corrective actions.   Training & Development: C oaches and mentors Process Engineer I and II staff on technology transfer, GMP practices, and problem-solving  methodology .   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;  participates  in annual product review and biennial critical systems review.   Education & Experience Minimum Qualifications: Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, with ability to independently apply controlled procedures and quality standards.  Training or experience in one or more of the following applicable MSAT-relevant technology areas: programmable logic controllers, computerized systems, vision systems, aseptic/controlled environment, formulation, aseptic filling, assembly, packaging, process validation, technology transfer, change control.  Demonstrated  proficiency  in  more than  one of  the following disciplines: automation/controls, prep, formulation, aseptic filling, assembly, packaging equipment, development and implementation of automated visual inspection tools, technology transfer, or validation. Demonstrated ability to coach and mentor peers on  applicable  MSAT processes . Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts. Preferred Qualifications: Bachelor’s degree in engineering or related science.  4+ years of experience in a GMP or regulated pharmaceutical manufacturing or MSAT environment.  Demonstrated project management experience managing technology transfer workstreams through PPQ completion.  Experience with Six Sigma, analytical troubleshooting, or LEAN manufacturing.  Physical & Work Environment Work is performed in a combination of office and cGMP manufacturing environments. Requires gowning and adherence to cleanroom, PPE, and safety requirements. Occasional lifting of up to 20 lbs; ability to stand, walk, and access equipment on the manufacturing floor. May require on-call support and occasional work outside standard business hours. The items described here are representative of those that must be met successfully to perform the essential functions of this job. Work Schedule Monday- Friday; dayshift The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration