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Engineer – Biopharma (JP8213)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Engineer – Biopharma (JP8213)
Location: Thousand Oaks, Ca
Employment Type: Contract
Business Unit: Final Product Technologies
Duration: 12 months with likely extensions
Job posting date: 2/11/2021
Note: Working onsite 1-2 days/week during COVID-19.
3 Key Consulting is hiring an Engineer for a consulting engagement with our client, a leading global bio-pharmaceutical company.
Must have skills:  
  • Combination product or medical device experience
  • Electro-Mechanical experience.

Job Summary:
The device engineer will partake in the design development and lifecycle management related activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, developing test procedures, scale-up and global launch, supplier development, and continuous improvement. The device engineer supports programs under the direction of senior engineers.
Scope includes electro-mechanical delivery devices, such as: fluid transfer devices, automatic pen injectors, or reusable automatic injectors. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these systems are maintained. The engineer will participate in multi-functional teams, supporting device design activities such as developing product improvements, supporting new development project teams, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Basic qualifications:
  • PHD
  • Masters degree with 1 Yoe
  • Bachelors degree and 2 Yoe
• Develop protocols for product testing.
• Develop, execute, and report technical analyses.
• Develop, execute, and report verification methods and testing.
• Communicate effectively at multiple organizational levels on project status, risks, issues, and accomplishments.
• Review technical reports and provide assessments of adequacy.
• Utilize project planning and monitoring methods to ensure timely completion.
• Ensure compliance to Regulatory and Quality requirements when generating design outputs and conducting technical reviews.
Top Must have Skill Sets:
  1. Ability to work on multiple projects at the same time under a define schedule.
  2. Resume well organized and clearly written.
  3. Experience in a regulated environment, preferably medical.
Employee Value Proposition:
Works on auto injector and suppliers all around the world.

Red Flags:
  1. no experience in regulated industry such as medical device or aerospace
  2.  unexplained periods without employment
  3. Software degree
Interview Process:
Video conference call.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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