Alternating Sat and Sun-Tues 6pm to 7am Responsibilities Understand process theory and equipment operation, supporting biopharmaceutical manufacturing processes including mammalian cell culture, filtration, chromatography, centrifugation, and formulation of bulk drug substance. Support initiatives for process optimization, identify and elevate processing issues, and support solutions. Gain experience with automation systems such as LIMS, MES, and PI. Provide feedback and suggested changes to operational procedures, assist in incorporating new technologies, and review process documents. Understand and utilize cGMPs and quality systems including Deviations, CAPAs, Change Requests, and Action/Alert Reports. Participate in projects, contribute to outcomes, and support new business systems like Trackwise and ERP. Support trending of department metrics. Perform strenuous, repetitive work involving bending, reaching, climbing stairs/ladders, kneeling, and equipment connections. Regularly lift, dispense, push, and pull items weighing approximately 25 pounds. Work around loud equipment and use personal protective equipment as required. Support various shift schedules and off-hours as needed. Requirements Bachelor's degree in science or engineering, or Associates degree in science or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry. Strong verbal and written communication skills. Ability to work effectively in a team environment, demonstrating conflict resolution and collaboration. Good initiative to identify areas for improvement and implement solutions. 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.
