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Engineer, Medical Device Combination Product​​​​​​​ (JP9630)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Engineer, Medical Device Combination Product (JP9630)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/5/2022
Note: Partially remote (50% remote/working on site 50% during COVID)

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Ideal candidate:
  • BS in engineering or life sciences with experience in technical writing, CAD design, SolidWorks, method validation, mechanical modeling, manufacturing experience, teamwork and communication skills.
  • 1-2 Years of industry experience (outside of academia) required.
  • Not considering BS degree with no experience. Will consider a Master’s degree with no experience as the client is willing to train.
  • This position involves support of senior staff in the design, development, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers.
  • The particular focus would be on qualification and validation of container closure integrity methods.
  • Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university.
  • They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques.
  • Candidates with a master’s degree in mechanical or electrical engineering with following skills are preferred: statistical analysis, optical measurement devices, test method development, CAD design, SolidWorks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ, teamworking and communication skills.

Top Must have Skill Sets:
  • Technical Writing
  • Mechanical Design (CAD)
  • Testing/test method development

Day-To-Day Responsibilities:
  • Evaluating and assessing the existing test method, both their documentation and their implementation in the field.
  • Modifying and improving the test methods, if necessary.
  • Creating a qualification, validation and transfer plan for the test methods, when required.
  • Performing and operating the tests required for qualification, validation and transfer of the methods.
  • Creating training documents.
  • Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.
  • Supporting routine testing and device disassembly as necessary

Employee Value Proposition:
  • Good way to get foot in the door and get hands on experience with combination products and testing.
  • Great opportunity for growth for younger engineers.

Red Flags:
  • No previous industry experience
  • Does not like to work in teams
  • Not considering BS degree with no experience.

Interview Process:
  • Phone screen with hiring manager
  • Panel interview (virtual) with team

 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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