Sr. Process Engineer

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The engineer will Implement process technology transfers of all cell therapy products.

External US

FUJIFILM Diosynth Biotechnologies California, Inc.

Sr. Process Engineer

Newbury Park, California

Job Duties: Implement process technology transfers of all cell therapy products. Support manufacturing processes and quality control related critical investigations. Author technical reports, technology/method transfer protocols, study protocols, and product impact assessments. Revise batch production records, process risk assessments (FMEA), technical assessments, and

memorandums in support of various Quality Management System (QMS) records; and Drive critical drug product particulate projects to completion. Employ cell culture processing and cell

therapy manufacturing principles and techniques. Perform investigational activities, fishbone analyses, and impact assessments. Conduct cell growth analyses to check cell viability. Perform raw materials analyses for manufacturing processes. Identify analytical instrumentation/methods employed for cell characterization. Conduct failure modes and effects analysis (FMEA) and hazard/operability (HAZOP) related activities to support quality by design (QBD). Review manufacturing documents including batch production records (BPRs), standard operating procedures (SOPs), and product specifications as necessitated by process changes. Provide manufacturing support work to the manufacturing cleanroom, including process characterization studies and process engineering and validation. Implement good manufacturing practices (GMP) and proficiency in their application in manufacturing.

Requirements: Master’s Degree in Chemical Engineering, Biological Physics, or Biochemical Engineering or equivalent and two (2) years of experience in a related process engineering position, including one(1) year of experience in: employing cell culture processing and cell therapy manufacturing principles and techniques; performing investigational activities, fishbone analyses, and impact assessments; conducting cell growth analyses to check cell viability; performing raw materials analyses for manufacturing processes; identifying analytical instrumentation/methods employed for cell characterization; conducting failure modes and effects analysis (FMEA) and hazard/operability (HAZOP) related activities to support quality by design (QBD); reviewing manufacturing documents including batch production records (BPRs), standard operating procedures (SOPs), and product specifications as necessitated by process changes; providing manufacturing support work to the manufacturing cleanroom, including process characterization studies and process engineering and validation; and implementing good manufacturing practices (GMP) and proficiency in their application in manufacturing.

Salary: $125,000 to $135,000 / year