Associate Engineer – Primary Container Testing, Characterization & Qualification (Biopharmaceuticals) - JP16067
About The Position
The Associate Engineer supports the Container Science and Engineering department within MSE under CPO in Thousand Oaks, California. The role supports senior staff in initiating, designing, and delivering projects, particularly those involving primary container design, characterization, and qualification. It applies engineering principles, technical skills, and cross-functional communication to support projects involving new or modified products, processes, tooling, or equipment, with the aim of improving quality and reliability and reducing cost. The position involves gathering user requirements and translating them into technical documentation, supporting engineering studies and assessments of drug delivery systems, analyzing data to inform decisions, and assisting with qualification of new primary container platforms. It also provides hands-on technical support for primary component issues related to customer complaints, aseptic filling, lyophilization, and inspection operations in commercial biopharmaceutical manufacturing. The Associate Engineer works with engineers and senior staff to design studies, draft protocols, compile historical data from different analytical systems, analyze and present results, write summary reports, and execute protocols and laboratory testing. The position is a contract engagement for 18 months, with a possible extension. It is hybrid, with onsite work in Thousand Oaks three days per week. Candidates should be within a 50-mile drive or willing to relocate. Overtime may be needed; workdays exceeding 12 hours are rare.
Requirements
- Bachelor’s degree, or associate degree plus 4 years of experience, or high school diploma/GED plus 6 years of experience.
- Strong oral communication and presentation skills.
- Strong technical writing skills are preferred.
- Must be able to work onsite in Thousand Oaks, California, three days per week.
- Must be flexible to work overtime when needed.
Nice To Haves
- Bachelor’s degree in Science or Engineering; a bachelor’s degree in Bioscience or Engineering is preferred.
- Experience analyzing data generated from a variety of analytical techniques and systems.
- Previous experience in engineering or biochemistry laboratories.
Responsibilities
- Gather user requirements and translate them into technical documentation for execution.
- Support project definition through engineering studies and assessments of drug delivery systems.
- Analyze data in detail to support informed decisions by senior staff.
- Perform engineering studies and assessments for device and primary container characterization and qualification.
- Assist in qualifying new primary container platforms.
- Provide hands-on technical support for primary component issues involving customer complaints, aseptic filling, lyophilization, and inspection operations in commercial biopharmaceutical manufacturing.
- Design studies and draft protocols.
- Compile historical data from different analytical systems.
- Analyze data and present results.
- Write summary reports.
- Execute protocols and perform laboratory testing.
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What This Job Offers
Career Level
Entry Level
Education Level
High school or GED
