Job Description :
We are seeking a Process Engineer for a a highly motivated individual with biotechnology experience to work on innovative T-Cell 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 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.
Requirement :
Basic Qualifications :
- BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience oro AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience oro HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalentPreferred 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
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Basic Qualifications:• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience oro AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 ye...
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