Job description – Process Engineer

Position Summary
This position provides on-the-floor manufacturing support to address deviations, support change control and CAPA, as well as supporting process monitoring, technology transfer, and manufacturing process troubleshooting as needed. Qualified candidates should have demonstrated technical proficiency in cell therapy manufacturing, a strong understanding of cGMP, initiative and collaboration with others.

 

Primary Responsibilities

  • Supports investigations of process failures including on-the-floor execution of investigation studies.
  • Champions maintenance of process monitoring database and support tracking and trending activities.
  • Performs technical assessments for deviations, change controls, CAPAs.
  • Authors, reviews and edits manufacturing documents including SOPs, batch records, specifications as necessitated by process changes.
  • Reviews and edits executed batch records, validation protocols and reports to assure appropriate and complete content.
  • Provides technical expertise and participates in FMEA, HAZOP related activities to support quality by design (QBD).In collaboration with other development functions at Cognate, assures effective transfers and start-up of new processes at Cognate external manufacturing site.
  • Supports training of manufacturing staff.
  • Role model for Cognate Values of patients first, innovation, teamwork

 

Position Requirements

  • Solid communication skills (e.g., clear and concise) both verbal and written.
  • Works well in a team-based environment; solid interpersonal and teaming skills. Good decision making with strong judgment through collaboration and consideration of others point-of-view.
  • Self-motivated and able to organize tasks and time to maximize effectiveness and efficiency.
  • Able to understand and interpret data/information and its practical application.
  • Fundamental knowledge of cell culture and cell processing principles and techniques, as well as an understanding of analytical.
  • Instrumentation/methods employed for cell characterization.
  • Strong understanding of GMPs and proficiency in their application in manufacturing.
  • Excellent technical writing skills.
  • Experience with technology transfers and manufacturing cell therapy products preferred.

 

Education and Experience

  • Bachelor’s degree in a biological or engineering science, with at least 3 years of relevant industry experience.

 

Travel

Ability to travel up to an average of 10% of work schedule.

 

Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, laboratory, or manufacturing environment. Car and airplane travel is an essential part of the job.

 

To apply, please submit your Resume and Cover Letter to hr@cognatebioservices.com