Process Engineer I, Cell Therapy in El Segundo, CA at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

Job Description


A well-regarded company focusing on patient therapies is seeking a Process Engineer I, Cell Therapy to join their team. This is a great opportunity to work for an industry leader!

This is a direct hire opportunity; if hired, applicant must be flexible with either working Tuesday - Saturday OR Sunday - Thursday between 7:00am - 4:00pm OR 2:00pm - 11:00pm.

RESPONSIBILITIES:

  • Provide front line technical support for manufacturing of products
  • Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues
  • Partner with other teams to execute process development studies within commercial facility to further develop a thorough understanding of operating and performance parameters
  • 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
  • Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
  • Trends key performance metrics
  • Participates in internal audit/inspection
  • Represents Manufacturing operations in Change Control, CAPA and Deviation meetings
  • Conducts technical training and guidance to manufacturing associates
  • Participates in the implementation of ERP systems
  • Other tasks and duties as assigned by management

REQUIREMENTS:

  • BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 5+ years of experience.  Engineering degree preferred
  • Cell culture 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
  • Skilled at 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.

If interested, please apply with an updated resume or email to Nancy at nnguyen@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.