Associate Engineer – Primary Container Testing, Characterization & Qualification (Biopharmaceuticals) - (JP16064)

3 Key Consulting • Thousand Oaks, CA

5d • Hybrid

About The Position

The Associate Engineer supports senior staff in the initiation, design, and delivery of projects focused particularly on primary container design, characterization, and qualification. The position is in the Container Science and Engineering department within MSAT (Manufacturing Science and Technology), under CPO (Combination Product Operations), and applies engineering principles to project work. The role requires technical skills and coordination and communication across functions, as well as the ability to manage multiple projects involving changes or new products, processes, tooling, or equipment to improve quality and reliability and reduce cost.

The Associate Engineer assists engineers with study design and protocol drafting, compiling historical data from different analytical systems, data analysis and presentation, summary report writing, and protocol execution, including laboratory testing. The position also provides hands-on technical support for primary component issues involving customer complaints, aseptic filling, lyophilization, and inspection operations for commercial biopharmaceutical manufacturing. The role is hybrid in Thousand Oaks, California, with an expectation of working onsite three times per week.

Requirements

• Bachelor’s degree, or an associate degree and 4 years of experience, or a high school diploma/GED and 6 years of experience.
• Strong ability to analyze data generated from a variety of analytical techniques and systems.
• Strong technical writing skills.
• Strong oral and verbal communication and presentation skills.
• Flexibility to work overtime during the week when necessary.
• Ability to work onsite in Thousand Oaks, California three times per week.

Nice To Haves

• Bachelor’s degree in Bioscience, Science, or Engineering.
• Previous laboratory experience; experience in engineering or biochemistry labs is helpful but not required.
• Experience analyzing data generated from a variety of analytical techniques.

Responsibilities

• Use basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.
• Assist with project definition by conducting engineering studies and assessments for drug delivery systems.
• Provide detailed data analysis to support senior staff decision-making.
• Conduct engineering studies and assessments for device and container characterization and qualification.
• Assist in qualifying new primary container platforms.
• Provide hands-on technical support for primary component issues related to customer complaints, aseptic filling, lyophilization, and inspection operations in commercial biopharmaceutical manufacturing.
• Assist engineers with designing studies and drafting protocols.
• Compile historical data from different analytical systems, analyze data, and present results.
• Write summary reports and execute protocols, including laboratory testing.

What This Job Offers

• Career Level: Entry Level