Manufacturing Engineer I performs the manufacture of cellular drug therapies within a GMP setting for ongoing product pipelines. Operates under current regulations and company policies. Participates in the lifecycle of manufacturing from preparation to support of product release.
Responsibilities:
Manufacture of CAR-T cell therapy products by executing batch records in compliance with current regulations and quality standards.
Perform Manufacturing new hire training and assessments.
Operate cell manufacturing equipment and instrumentation as part of batch record execution.
Work both independently and cross-functionally with Quality, MSAT, Supply Chain, EHS and Facilities to ensure safe and effective manufacturing of patient's products.
Perform data entry and accurate calculations to determine cell concentration, cell viability and dilutions.
Routine preparation and maintenance of cell culture reagents and media.
Perform verification steps assuring any batch record errors and or deviations are addressed and resolved.
Meticulous attention to detail and high level of accuracy in lab work and documentation.
Application of aseptic techniques.
Ensure proper operation and performance of manufacturing equipment and accurately complete equipment logbooks.
As required, participate in the manufacturing equipment cleaning program and work to assure all critical environments are maintained per qualified methods.
Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.
Qualifications:
Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.
Bachelor's degree in a related scientific or engineering discipline with 5+ years' experience related GMP manufacturing operations or 3+ years' experience in related GMP manufacturing operations with Master's degree or 0+ years' experience in related GMP manufacturing operations with Terminal degree.
Experience with cell culture, cryopreservation, purification, filling and aseptic processing, CAR-T manufacturing a plus.
Experience with cell processing and manufacturing equipment such as bioreactors, cell counters, incubators, centrifuges, Biological Safety Cabinets, pipettes and other common cleanroom equipment.
Ability to read and adhere to SOPs and current Good Manufacturing Practices to ensure quality of product.
Ability to gown appropriately for cleanroom manufacturing.
Understanding of cGMP documentation and practices.
Highly ethical and transparent with professional sensitivity and care with confidentiality.
Strong communication, written and verbal and strong organizational and time management skills.
Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.