Process Engineer - Cell Therapy Process Design

Job Description

Under minimal supervision, the main accountabilities are focused on the front line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.

Responsibilities (include but are not limited to):
Provide front line technical support for manufacturing of cell therapy products
Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues
Partner with Product Sciences Team to transfer new processes into manufacturing
Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
Devises and implements CAPAs to address root cause and ensure effectiveness
Trends key performance metrics
Participates in internal audit/inspection
Represents Manufacturing operations in New Product Introduction meetings
Conducts technical training and guidance to the Cell Therapy Specialists on new processes and technologies
Other tasks and duties as assigned by Management

Requirements:
BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 2+ years of experience. OR

AS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 4+ years of experience.

High School Diploma with 5+ years of experience.

Additional Requirements:

Engineering degree preferred
Cell culture, Cell therapy and/or aseptic processing experience
Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
Experience with investigation and root cause analysis tools
Experience creating and delivering presentations
Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project
Utilizes technical writing strategies to ensure content is clear and concise
Possesses good communication skills
Experience leading cross functional teams to obtain 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 ERP systems implementation is desirable