Process Engineer

Job Title: Process Engineer Pharmaceuticals ILocation: Research Triangle Park, NC Duration: 234 daysSummary of Job:Seeking a contract Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support of AAV (rAAV) vector research and late-stage clinical gene therapy programs. This role is execution-focused, supporting upstream and downstream manufacturing operations, routine experiments, and process development studies working in close coordination with manufacturing and MSAT staff. The contractor will contribute to the timely completion of manufacturing and laboratory studies, data collection, and manufacturing readiness ensuring alignment with existing protocols to support early-stage gene therapy programs, technology development, and internal research priorities. This is a laboratory-based contract role intended to support day-to-day manufacturing and experimental execution working closely with pre-clinical manufacturing and MSAT scientists. This role does not carry people-management or long-term program ownership responsibilities and is well suited for individuals who thrive in an execution-driven environment..Must-have/Required skills:BS or MS degree in a biological or engineering discipline required (Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or equivalent) Minimum 2 years (BS)/0 years (MS) of relevant experience in laboratory research, biologics manufacturing and a desire to continue in a laboratory-focused role, preferably within: Manufacturing, MSAT, Process DevelopmentExperience or familiarity with upstream and/or downstream bioprocess operationsComfort executing experiments under direction, following protocols, and meeting scheduled deliverablesAbility to work on-site in a fast-paced laboratory environmentNice-to-have Skills:Prior exposure to cGMP manufacturing environments or manufacturing-support laboratoriesHands-on experience executing scale-up, scale-down, or process characterization experimentsFamiliarity with DOE concepts and experimental execution (design and analysis support may be provided by others)Experience using JMP or similar statistical tools (execution-focused)Strong working knowledge of Microsoft Word, Excel, and PowerPointExcellent attention to detail and data accuracyKey Responsibilities and Duties:Execute routine and defined rAAV manufacturing and laboratory activities for research and GLP-grade studies following established protocols and batch recordsPerform hands-on upstream and downstream operations, including:Cell culture and maintenanceVector production in shake flasks, WAVE bioreactors, and/or stirred-tank bioreactorsCentrifugation, filtration, chromatography, and related purification stepsSupport process development and experimental studies, including process characterization and robustness testing, at small and pilot-scale by executing assigned experiments and manufacturing runs according to approved protocols, batch records, and study plans, ensuring accurate data generation and traceabilityMaintain clear, real time and accurate documentation of laboratory activities, experimental results, and manufacturing data in paper or electronic systems in accordance with department procedures to ensure compliance and data integrityAssist with batch record completion, data compilation, and data reviewCommunicate experimental progress, observations, and results to project stakeholders in a clear and timely mannerSupport manufacturing investigations and troubleshooting activities, including execution of confirmatory experiments and data collection to inform root-cause analysisContribute to technical protocols, experimental reports, and summary presentations describing executed work and generated data, as neededSupport daily laboratory operations, including:Equipment setup, operation, and routine maintenanceCoordination and execution of laboratory activitiesMaintaining a clean, organized, and inspection-ready lab environmentEnsuring materials, consumables, and reagents are available for assigned experiments in coordination with lab management and solution prep teamsFollow established safety procedures, SOPs, and documentation practices at all timesAdhere to all safety, quality, and data integrity requirements during laboratory and manufacturing-support activities