Engineer, Primary Container Testing, Characterization & Qualification - Biopharma/Medical Device - (JP16093)
About The Position
The Contract Engineer will support the Container Closure Integrity (CCI) team in initiating, developing, qualifying, and executing projects related to package integrity and sterility assurance for pharmaceutical drug products. Working closely with senior engineers and scientists, the engineer will contribute to method development, qualification activities, technical studies, and laboratory investigations using various CCI technologies. The role includes helping design and execute experimental studies, collecting and analyzing data, preparing technical documentation, supporting test-method development and optimization, and translating project requirements into executable protocols and reports. The engineer will also contribute to equipment evaluations, troubleshooting, laboratory automation initiatives, and adoption of technologies intended to improve testing efficiency and reliability. This is a contract consulting engagement with a leading global biopharmaceutical company. The role is based in Thousand Oaks, California, with a hybrid schedule requiring onsite work two days per week. The stated duration is 18 or more months, with likely extensions and/or conversion to permanent employment.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related technical field.
- Zero to three years of relevant industry experience.
- Strong technical writing and data analysis skills.
- Ability to work independently while supporting multiple projects in a collaborative environment.
- Engineering or science background and a solid understanding of engineering or science fundamentals.
- Good communication skills.
Nice To Haves
- Internship or co-op experience in a pharmaceutical, medical device, biotechnology, or engineering environment.
- Exposure to container closure integrity (CCI), sterile product manufacturing, pharmaceutical packaging, or analytical test methods.
- Experience with laboratory equipment, instrumentation, automation systems, robotics, or computer-controlled systems.
- Familiarity with Excel, JMP, Minitab, or similar statistical software.
- Basic programming experience with Python, VBA, MATLAB, LabVIEW, or similar.
- Strong problem-solving, organizational, and communication skills.
Responsibilities
- Support development, qualification, and lifecycle management of container closure integrity test methods.
- Assist with designing and executing experimental studies, engineering studies, process characterization, and design verification activities.
- Perform laboratory testing and collect and analyze data.
- Develop or optimize test methods for new or existing instruments.
- Generate and review technical documents, including protocols, reports, work instructions, and standard operating procedures.
- Support data analysis, trend evaluations, and investigation activities.
- Collaborate with Process Development, Manufacturing, Quality, Packaging Engineering, Analytical Sciences, and other cross-functional teams.
- Evaluate existing systems and recommend process improvements or automation opportunities.
- Support equipment evaluations, troubleshooting, laboratory automation initiatives, and implementation of new technologies.
- Maintain compliance with GMP, data integrity, and documentation requirements where applicable.
Benefits
- Benefits are mentioned as part of the W2 pay arrangement, but specific benefits are not listed.
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What This Job Offers
Career Level
Entry Level
