Joulé
Title: GMP Laboratory Technician Location: Onsite, Pittsburgh, PA 15219 Type: 6-month contract to hire Hours: 8AM-5PM Start: November Overview: Join a Cell Therapy manufacturing department in which you will play a critical role in producing cell-based therapies, working in a GMP-regulated facility. This role supports manufacturing activities from cell culture through product harvesting and cryopreservation, ensuring high-quality cell therapy products are produced in accordance with Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs). Responsibilities Cell Therapy Manufacturing: Perform aseptic mammalian cell culture processes, including cell selection, gene editing, activation, expansion, harvesting, formulation, and cryopreservation, in compliance with cGMP standards. Execute all daily operations on schedule and adhere to approved procedures. Monitor cleanroom activities to ensure compliance with SOPs and current Good Manufacturing Practices (cGMP) requirements. Operate and maintain cell therapy manufacturing equipment such as incubators, biosafety cabinets, and centrifuges, ensuring they meet operational standards. GMP Compliance: Adhere to cGMP guidelines during all manufacturing operations, maintaining documentation and following SOPs. Ensure that manufacturing activities are consistently performed in an audit-ready state, with strict adherence to regulatory and safety requirements. Support deviation investigations, CAPAs, risk assessments, and change controls. Cross-functional Roles: Work closely with Quality Assurance (QA), Quality Control (QC), and other departments to ensure smooth production and resolve any process-related issues. Participates with the product development team and performs assigned tasks Participate in team meetings and contribute to process optimization discussions, fostering a culture of continuous improvement. Documentation and Reporting: Enter production data from batch records into established databases. Accurately document production operations in electronic batch records or log sheets following cGMP and SOP requirements. Assist in troubleshooting and reporting deviations or potential issues during production to senior staff for resolution. Requirements Bachelor’s degree in biology or a related field with laboratory experience in molecular cell biology, cell culture, and basic analytical techniques. Be self-driven, sincere, thorough, and have an eye for details. Candidates with demonstrable experience in cell and gene therapy manufacturing or working in a controlled GMP environment in academic or industry settings are preferred. System One, and its subsidiaries including Joulé, ALTA IT Services, 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. #M3 #LI- #DI- Ref: #558-Scientific