Job Title: Engineer (JP9840)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 18 months with likely extensions
Job posting date: 2/23/2022
Note: Onsite M-F normal core hours

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

Job Summary:

Ideal candidate-

• BS or MS 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, technical writing.
• This position involves support of senior staff in the design, development, qualification, validation and transfer of 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 inspection and dimensional measurement methods.
• The 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 design and manufacturing of test fixtures.
• 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, teamwork and communication skills.

Top Must have Skill Sets:

• Statistical Analysis
• GMP Documentation
• Method Validation
• Communication skills
• Ability to work with standard operating procedures and FDA guidelines

Day-To-Day Responsibilities:
The worker will be expected to develop test procedures, and qualification/validation strategies for these procedures according to Good Manufacturing Practices. Daily activities will vary between:

• Drafting GMP documentation
• Developing fixturing and CAD
• Planning and executing validation activities
• Attending and coordinating meetings

Employee Value Proposition:
The person in this role will gain experience in a GMP environment and developmental methods. You will also build PM skills and statistical analysis skills

Red Flags:

• No collaboration and communication skills
• No engineering/technical experience
• Large gap in work experience without justification
• jumpy job history

Interview Process:
1. Phone screen
2. Panel interview with team
3. Q&A 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 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.