Process Engineer III- Tech. Ops Readiness Team

职位描述

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 establishing a Manufacturing Technical Services team dedicated to startup and support of our new commercial cell therapy manufacturing facility in Frederick, MD. We are seeking multiple highly motivated Process Engineers to represent Manufacturing Technical Services on multi-disciplinary teams including those responsible for technology transfer, product lifecycle management, quality record management, process investigations, continuous improvements, and site projects.

Responsibilities (include but are not limited to):

• Ensure successful manufacturing production runs by assessing risk, implementing preventive measures, investigating, and troubleshooting process issues

• Represent Manufacturing during the technology transfer of clinical and commercial products to the site

• Lead Manufacturing Operational Readiness activities as part of technology transfer of new processes.

• Author/Review/Approve GxP Documents such as Change Controls/SOPs/Training material to support technology transfer/process improvements.

• Partner with MSAT to implement studies in a laboratory setting to support investigations and continuous improvement efforts

• In conjunction with various internal and external partners, investigate and coordinate the timely resolution of deviations through comprehensive use of Root Cause Analysis tools

• Devise and implement CAPAs to address root cause and ensure effectiveness

• Trend key performance metrics

• Participate in internal and external audits/inspections

• Develop training content and conduct training sessions for Cell Therapy Specialists

• Work with Supply Chain to establish bill of materials and establish cost of goods manufactured

Basic Qualifications

• MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology with 3+ years of relevant experience or

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+ years of relevant experience or

• Associates in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology with 7+ years of relevant experience or

• HS Diploma with 9 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology

Requirements / Qualifications:

• Cell therapy, cell culture and/or aseptic processing experience

• Broad knowledge of cGMP compliance and experience with leading investigations, deviation reports, change controls, and assignment of corrective actions

• Experience with root cause analysis tools and proficiency in Quality Systems

• Skilled at creating and delivering presentations

• Possess excellent communication and technical writing skills

• Experience leading cross functional teams to achieve project deliverables

• Working knowledge of scientific and engineering principles

• Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

• Knowledge of manufacturing execution systems (MES) is desirable