Engineer, GMP Facilities & Equipment, Drug Substance Process Support (JP15973)

3 Key Consulting • Thousand Oaks, CA

1d • Onsite

About The Position

3 Key Consulting is hiring an Engineer for a consulting engagement with a direct client, a leading global biopharmaceutical company. The position supports manufacturing and engineering staff with ongoing troubleshooting and improvements to the manufacturing process. It includes initiating, executing, and completing continuous improvement projects, particularly those involving equipment.

The role provides hands-on field support and field evaluations, makes engineering design recommendations, and escorts third-party vendors. It involves cross-functional collaboration with maintenance, instrumentation, manufacturing, quality, and process engineering teams in a GMP/FDA-regulated cleanroom. The position is onsite on the day shift in Thousand Oaks, California. The contract is for at least one year, with likely extensions and/or conversion to permanent employment.

Requirements

• GMP experience.
• Hands-on troubleshooting experience.
• Root cause analysis experience.
• Biotechnology or pharmaceutical industry background.
• Master’s degree, or a bachelor’s degree and 2 years of engineering or operations experience, or an associate’s degree and 7 years of engineering or operations experience, or a high school diploma/GED and 8 years of engineering or operations experience.
• Experience with Maximo.
• Experience analyzing obsolete components and functional equivalence.

Nice To Haves

• Previous internship experience.
• Experience with automation, including DeltaV.
• Computer programming experience, including SQL, VBA, or PLCs.
• Experience with drug substance systems and/or chromatography, filtration, single-use and stainless-steel product trains, and various mixers.

Responsibilities

• Troubleshoot manufacturing equipment and support improvements to the manufacturing process.
• Initiate, execute, and complete continuous improvement projects, particularly equipment-related projects.
• Provide hands-on field support and conduct field evaluations.
• Provide engineering design recommendations.
• Escort third-party vendors.
• Collaborate with maintenance, instrumentation, manufacturing, quality, and process engineering teams within a GMP/FDA-regulated cleanroom.
• Perform root cause analysis.
• Provide system ownership and lifecycle management.
• Coordinate preventative maintenance and calibration.

What This Job Offers

• Education Level: High school or GED