Aseptic Manufacturing Validation Engineer Support validation activities for aseptic manufacturing systems, equipment, utilities, and facilities. This role is responsible for qualification, protocol execution, documentation, compliance support, and ongoing validation of production and utility systems within a cGMP-regulated biopharmaceutical environment. Execute validation and qualification activities for autoclaves, depyrogenation tunnels, filling lines, HVAC systems, cold rooms, freezers, warehouses, and pharmaceutical utilities. Perform smoke studies, support media fill qualifications, and provide subject matter expertise for aseptic processing validation activities. Author and execute validation protocols, periodic reviews, qualification documents, and final reports. Support change controls, deviations, CAPAs, risk assessments, and development of validation lifecycle documentation including URS, FRS, and design qualification deliverables. Partner with Engineering, Maintenance, and Production teams to support equipment selection, upgrades, compliance readiness, and regulatory inspections. Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. Experience performing validation activities within a cGMP-regulated pharmaceutical, biopharmaceutical, or biotechnology manufacturing environment. Knowledge of aseptic processing, sterilization systems, cleaning validation, smoke studies, media fills, and equipment qualification methodologies. Experience validating HVAC systems, pharmaceutical utilities, filling lines, autoclaves, depyrogenation tunnels, and controlled-temperature storage systems. Experience with validation documentation, CAPA investigations, change control processes, and regulatory requirements including FDA compliance standards; experience using Ellab data loggers and software preferred. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
