Process Engineer I - $8,000* Sign On

Job Description

We are seeking a Process Engineer I to support our commercial biotechnology facility in El Segundo. Under minimal supervision, this position’s main accountabilities are focused on the front line technical support of the Cell Therapy process. Under general supervision, this position’s main accountabilities are focused on the frontline support of manufacturing operations , equipment implementation, APVs, risk assessments, change control, CAPAs and process improvements.

Responsibilities include, but are not limited to:

• Provides front line technical support for manufacturing of cell therapy products
• Ensures successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment, process issues
• Partners with MSAT Team to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters
• Represents technical Operations in Change Control, CAPA and Deviation meetings
• 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
  • Initiates deviations and Change controls
• Collaborates with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
• Implements continuous design/process changes (low to mediun in complexity) that are required by the Business as a result of Change controls, CAPAs, Enhancements.
• Develops Work Instructions and SOPs to support the Process
• Point of contact for help and mentoring to business users of the process
• Develops training material and executes process changes and creation of SOPs
• Identifies additional training or self-help improvement needs and communicates recommendations
• Performs OQ/ PQ testings
• Reviews URS/ OP/PQ protocols
• Impact Assessor for proposed and upcoming changes in the process/system
• Participates in the implementation of different Projects
• Participates in internal audit/inspection
• Other tasks and duties as assigned by Management

Basic Qualifications:

• MA/MS Degree in Biochemical Engineering or Chemical Engineering OR
• Bachelor’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology with 2+ years of experience OR
• AA Degree with 4+ years of experience in Biochemical Engineering or Chemical Engineering OR
• High School Degree with 5+ years of experience in Biochemical Engineering or Chemical Engineering

Preferred Qualifications:

• Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
• Cell Therapy CAR-T process Knowledge
• 1+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
• 1+ years of experience with MES
• Possesses good communication skills

*This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.