Associate Engineer, Drug Manufacturing and Clinical Supply (JP14936)

3 Key Consulting • Thousand Oaks, CA

39d

About The Position

In this role you will be joining the Drug Product Pilot Plant team within the Manufacturing and Clinical Supply (MCS) organization Process Development. The team’s mission is to leverage industry-leading pilot plant capabilities for robust, efficient filling process characterization; support company’s drug product manufacturing network, including driving and supporting continuous improvement initiatives related to the filling unit operation; and produce Not for Human Use (NHU) material, freeing up capacity within the GMP plants.

Requirements

• Biopharma Manufacturing (fill-finish)
• Filling vials and syringes
• Equipment Engineering
• Problem Solving
• Strong Communication
• Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Responsibilities

• Set up and operate fill/stoppering equipment for drug product dispensing
• Perform format changeovers and material preparation
• Lead material generation runs for vial and syringe formats
• Execute fill process characterization studies following protocols
• Prepare lab notebooks, reports, and documentation
• Manage pilot plant raw materials
• Draft standard operating procedures (SOPs)
• Apply scientific and engineering principles to improve processes
• Present study results to management and product teams
• Support safety and compliance initiatives

What This Job Offers

• Career Level: Entry Level