Process Engineer I - MIT (Manufacturing Investigations Team)

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Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T-Cell therapies for cancer treatment. As a member of the Manufacturing Investigations Team (MIT - Process Engineer) you will be part of a team of investigators responsible for the examination and resolution of adverse events (quality events) that occur within manufacturing operations for Kite’s engineered T-Cell therapy products at the Frederick, Maryland site. 

Responsibilities Include (but are not limited to):

·       Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.

·       Initiate quality records in the Veeva Quality Management System (QMS).

·       Lead cross-function team meetings to perform complex root cause analysis (RCA).

·       Compile investigation results in a concise and comprehensive technical report format.

·       Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).

·       Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.

·       Provide timely progress updates to internal stakeholders, as required.

Basic Qualifications:

·       BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience or

·       AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 4 years of relevant experience or

·       HS Diploma with 5 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

·       Strong skill in technical writing

·       Strong skill in organization

·       Strong skill in root cause analysis

·       Experience in cell culture or aseptic processing

·       Experience in cGMP cell therapy manufacturing

Does this sound like you? If so, please apply today!

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