: Test Method and Validation Engineer (JP7321)
Thousand Oaks, CA
Final Product Technologies CORE
: 12 months with likely extensions
Job posting date
3 Key Consulting is hiring a Test Method Validation Engineer
for a consulting engagement with our client, a leading global bio-pharmaceutical company.
During COVID the CW will work remotely & will be required to be on site once campus opens.
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 sub-assemblies, including drug product containers. The particular focus would be on qualification and validation of visual test methods and dimensional measurements. Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. Expected to have strong technical writing skills and be familiar with different engineering measurement techniques. 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 measurement devices, test method development, CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ, teamworking and communication skills.
The test method validation engineer will primarily assist with evaluating and assessing the existing test methods (documentation as well as implementation in the field), modifying and improving them, and performing tests and other activities required for their qualification, validation and transfer. This includes creation and approval of any required documentation and may also include design and manufacturing of test fixtures.
Top Must have Skill Sets:
- Bachelor’s degree in an engineering field, technical writing, engineering measurement with 2+ years of industry experience
- Preferred Master’s degree in mechanical or electrical engineering
- Statistical analysis, knowledge of Gage R&R, optical measurement devices, test method development
- CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ,
- Teamworking and communication skills.
Employee Value Proposition:
- 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.
Position is cross functional with many departments - hands on exposure.
: Jumpy job history.
Screening phone/Skype interview
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.