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Joulé · 1 day ago

GMP Laboratory Technician

Pittsburgh, PA

Contract

Onsite

New Grad, Entry Level

Joulé is a leader in delivering outsourced services and workforce solutions across North America. They are seeking a GMP Laboratory Technician to play a critical role in producing cell-based therapies in a GMP-regulated facility, ensuring high-quality products are produced according to established standards.

Staffing & Recruiting

Growth Opportunities

Responsibilities

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

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

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

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

Qualification

Cell cultureGMP complianceMolecular cell biologyAnalytical techniquesAttention to detail

Required

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

Preferred

Candidates with demonstrable experience in cell and gene therapy manufacturing or working in a controlled GMP environment in academic or industry settings