IDM Test Methods & Systems Engineering

Skill Keywords:IQ/OQ/PQ, System Qualification, Test Method Transfer, Test Method Validation, Test Systems, Equipment Qualification, Method Validation, DOE, Statistical Analysis, Technology Transfer, Commissioning, Site Readiness, Validation, Deviations, Change Control, Root Cause Analysis, CAPA, GMP, Technical Documentation, Regulated ManufacturingJob Description & Skill Requirements:Support transfer, installation, qualification, deployment, and maintenance of manufacturing test systems.Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.Support test method transfers between manufacturing sites and external manufacturing partners.Execute test method validation, verification studies, and qualification protocols.Support commissioning, equipment startup, site readiness, and test system implementation activities.Perform Design of Experiments (DOE), statistical analysis, and technical evaluations.Support lifecycle management and sustainment of test methods and test systems.Troubleshoot test equipment, test systems, and test method-related issues.Support equipment maintenance, periodic reviews, system assessments, and continuous improvement activities.Support deviation investigations, root cause analysis, corrective actions, and change implementation.Develop and maintain qualification protocols, validation documentation, engineering reports, procedures, work instructions, and technical documentation.Maintain assigned systems and documentation in a state of qualification and audit readiness.Support training and knowledge transfer for operators, engineers, and manufacturing/site personnel.Coordinate with Test Methods Engineering, Project Management, Quality, Manufacturing, Product Stewardship, receiving sites, and external suppliers.Support global deployment and transfer activities across manufacturing sites and external partners.Travel up to 20% domestically and internationally to support system deployment, qualification, and method-transfer activities.Minimum Qualifications:Bachelor's degree in Engineering, Engineering Technology, Science, or related technical discipline.2–5 years of relevant engineering experience.Hands-on experience with engineering documentation, qualification protocols, validation documentation, and technical reports.Strong written and verbal communication skills.Ability to independently execute activities while supporting multiple projects.Highly Preferred Experience:System/equipment qualification – IQ/OQ/PQTest method transfer and/or technology transferTest method development, validation, or verificationTest system deployment and sustainmentAnalytical testing equipmentDOE and statistical analysisPharmaceutical, medical device, biotechnology, or other regulated manufacturing environmentsGMP/quality systemsDeviations, investigations, CAPA, and change controlCommissioning and manufacturing site readinessTechnical writing and validation documentationPrevious Eli Lilly experience is a strong plus