Engineer, Biotech Drug Delivery Medical Device
Engineer, Biotech Drug Delivery Medical Device This position reports into the Primary Container Engineering (PCE) department under the Manufacturing Science and Technology (MSAT) Group within the Combination Product Operations (CPO) in Thousand Oaks, CA. This position supports senior staff in the initiation, design, and delivery of projects, particularly in primary container design, characterization, and qualification. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, or processes introduction to improve quality and reliability and reduce cost. This role will be required to:
- Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.
- Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization/qualification in a GMP environment.
- Design and development of primary container systems.
- Design and development of physical test methods with respect to container and combination product integration of drug delivery systems.
- Provide detailed data analysis and recommendations to enable senior staff to make informed decisions.
Basic Qualifications:
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience.
Top Must Have Skill Sets:
- Proficiency in statistical and analytical methods such as but not limited to: Tolerance stack-up analysis, ANOVA, Gage R&R, T-Test, regression, etc.
- Proficiency in Solidworks/CAD/Drawings/Assemblies
- Strong oral and written (technical/non-technical) communication skills, including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
Day to Day Responsibilities:
- Drafting and getting a protocol approved
- Execute testing per protocol
- Compile results
- Data analyze the results and draw a conclusion/recommendation based on evaluated analysis
- Organize the outcome of the study in a presentable manner
- Present to management
Basic Qualifications:
- B.S. in Engineering
- Effective Communicator (Oral/Written)
- Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Why is the Position Open? Supplement additional workload on team. Red Flags:
- No engineering degree
- No experience with the 3 must have skills
Interview Process: Video Conference call (WebEx) We invite qualified candidates to send your resume to [email protected]. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.