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Process Engineer I

1 month ago

Frederick, United States Mindlance Full time

Job Title: Process Engineer - Manufacturing Investigations
Location - Frederick, MD
Onsite

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 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.

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 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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."