Process Engineer I

Job Title: Process Engineer Manufacturing Investigations

Location Frederick MD

Onsite

Kite is seeking a highly motivated individual with biotechnology experience to work on innovative TCell therapies for cancer treatment.

As a member of the Operations and Compliance Support team 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 Kites engineered TCell 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 crossfunction 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
o AA in Biochemical Engineering Chemical Engineering Biotechnology Chemistry Biology or equivalent with at least 6 years of relevant experience or
o HS Diploma with 8 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