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Mechanical/Test Method Validation Engineer - Medical Devices (JP7371)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Engineer – Medical Combination Devices Test Methods (JP7371)
Location: Thousand Oaks, CA. (50% Onsite Essential)
Employment Type:  Contract
Business Unit: Physical Methods Mechanical Engineering Gold Team
Duration: 18+ months (with likely extensions)
Posting Date: 6/16/20
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The Engineer will work under the team: Mechanical Engineering Methods. They will be responsible for engineering activities required for the development, qualification, validation, and transfer of Physical GMP Test Methods for combination products, devices, primary containers, and secondary packaging components. The Engineer will have the ability to work on projects that may involve changes or new product, processes, tooling, or equipment introduction to improve quality, reliability and reduce cost. Phases of projects include:
  • Developing combination product test methods.
  • Providing key expert support for qualification, validation, transfer.
  • Life cycle support of methods for manufacturing, new product introduction, training, and production support.
Why is the Position Open?
  • Planned project - group deals with developing test methods and validation of those methods. Drug product delivery system (fixture made, test procedures, etc.).
Top Must-Have Skill Sets:
  • Technical writing/lab documentation in academic - (1-2 years of experience).
  • Technical troubleshooting (mechanical &/or electrical).
  • Fixture/equipment design (2-3 year of experience).
  • CAD (computed aided design) - SolidWorks, Catia, AutoCAD (2 years of experience)
  • Excellent verbal and written communication skills.
  • Willing to work in a fast paced environment.
Basic Requirements:
Master's Degree or Bachelor's Degree and 2 years of engineering/scientific experience
Day to Day Responsibilities:
Phases of projects include developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.  Activities include:
  • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
  • Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.
  • Coordinate test method development and delivery with selected contractors and vendors.
  • Ensure that qualification parameters are met for product requirements.
  • Generate procedures necessary to support department and new process equipment.
  • Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
  • Participate in and assume responsibilities of team functions as assigned – i.e. subject matter experts for test equipment.
  • Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.
  • Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
  • Perform other duties as required by the Group Manager.
  • Comply with the requirements, responsibilities, and authority as required.
  • Communicate and collaborate internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
  • Network with manufacturing, quality and regulatory organizations both internal and external to client.
  • Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership.
Employee Value Proposition:
This position is a great way to begin or grow a career in medical device industry. Focuses primarily on test development, qualification and Validation practices, and transfer of processes to manufacturing sites. The team is full of a variety of backgrounds, creating a diverse work environment of new ideas and experiences. Has several open opportunities to advance your career. Contract possible of extension out to a total 3 years maximum.
Red Flags:
  • Poor communication.
  • No technical writing skills.
  • Lack of excitement for learning new things in the test method development.
Interview process:
Video Skype Panel Interview.
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.
3KC Talent Acquisition Team
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