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Engineer, Biotech Medical Device  (JP9459)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Engineer, Biotech Medical Device  (JP9459)
Location: Thousand Oaks, CA. (50/50 Onsite/Remote)
Employment Type:  Contract
Business Unit: 
Final Product Technologies CORE
Duration: 1+ years with likely extension or conversion to FTE
Posting Date: 11/18/2021

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

Job Description:
This position involves support of senior staff in design, development, qualification, validation and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on development, qualification and validation of visual test methods and dimensional measurements as well as the equipment used for testing. 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 and equipment.

Candidates having a master’s degree in mechanical or electrical engineering with the following skills are preferred:
  • Statistical analysis.
  • Knowledge of Gage R&R.
  • Optical and automated measurement devices.
  • Test method development.
  • IQ, OQ, and PQ.
  • CAD design.
  • SolidWorks.
  • Mechanical modeling.
  • Manufacturing experience.
  • Performance testing of shipping containers.
  • Knowledge of primary and secondary packaging.
  • Teamworking and communication skills.
T
he test method validation engineer will assist with, improving and validating existing test methods as well as designing, developing, validating and transfer of new test methods. These includes creation and approval of any required documentation and design and manufacturing of test fixtures.

Why is the Position Open?
Additional workload on team.

Top Must-Have Skill Sets:
  • Bachelor’s degree in an engineering field
  • Technical writing
  • Engineering measurement
  • Test methods

Day to Day Responsibilities:
  • Evaluating and assessing and modifying the existing test method, both their documentation and their implementation in the field.
  • Performing and operating the tests required for qualification, validation and transfer of testing equipment and methods.
  • Creating new test methods and the required test fixtures.
  • Creating a qualification, validation and transfer plan for the test methods, when required.
  • Creating training documents.
  • Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods

Preferred Qualifications:
  • Statistical analysis.
  • Knowledge of Gage R&R.
  • Optical and automated measurement devices.
  • Test method development.
  • IQ, OQ, and PQ.
  • CAD design.
  • SolidWorks.
  • Mechanical modeling.
  • Manufacturing experience.
  • Performance testing of shipping containers.
  • Knowledge of primary and secondary packaging.
  • Teamworking and communication skills.
  • Exposure to Control Systems and Databases a desirable.

Employee Value Proposition:
Great biotech/pharma to work for
New product introductions

Interview process:
Phone Screen

Panel WebEx Interview.

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 take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
Regards,
 
3KC Talent Acquisition Team
 
 
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