Job Title:  Validation Engineer (JP12116)
Location: Thousand Oaks, CA. 91320
Business Unit: Superior Systems Engineering
Employment Type:  Contract
Duration: 1+ years (with possible extensions)
Rate: $50 - $55/hour
Posting Date: 1/10/2024.
Notes: Only qualified candidates need apply.  Hybrid - Thousand oaks location candidate must be onsite 3 days a week.

3 Key Consulting is hiring!  We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have a Bachelor’s with 2 years of experience. Masters preferred. experience in the data analysis field. Medical Device, Mechanical, biomedical experience is also nice to have. Experience with CAD design, SolidWorks.

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.

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
• CAD design, SolidWorks
• Mechanical modeling
• Manufacturing experience
• IQ, OQ, and PQ, performance testing of shipping containers
• Knowledge of primary and secondary packaging
• Teamworking and communication skills.

The 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 the creation and approval of any required documentation and also design and manufacturing of test fixtures.

Top Must Have Skill Sets:
Bachelor’s degree in an engineering field, technical writing, engineering measurement

Day to Day Responsibilities:

• Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• Creating all the required documents for qualification, validation and transfer of test methods.
• Create, revise parts and drawings using CAD software (SolidWorks Preferred).
• Perform data analysis using Minitab and interpret data.
• 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.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:

• Statistical analysis
• Knowledge of Gage R&R
• Optical and automated measurement devices
• Test method development
• CAD design, SolidWorks
• Mechanical modeling
• Manufacturing experience
• IQ, OQ, and PQ, performance testing of shipping containers
• Knowledge of primary and secondary packaging
• Teamworking and communication skills.

Why is the Position Open?
Supplement additional workload on team

Red Flags:

• No bachelors degree
• Candidates that are too far to commute.

Interview Process:

• Phone call (Hiring manager): 30- 45 minutes
• Panel Interview, immediate team (video): 1 hour
• Panel Interview, managers (video): 1 hour

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We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  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.