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Engineer-Medical device Combination product (JP9680)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title:   Engineer-Medical device Combination product (JP9680)
Location: Thousand Oaks, CA
Employment Type: Contract
Business Unit: Modeling and Emerging Technology
Duration: 18 months with likely extensions
Job posting date: 1/19/2022
Note: Onsite Essential

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

Job Summary:
  • B.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or Materials Science
  • The Engineer, in Final Product Technologies- Mechanical Engineering Methods, is 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 shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost.
  • 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.

Top Must have Skill Sets:
  • 2+ years 3D CAD design/ Solid Works Experience
  • Proficient in Technical Writing and Documentation
  • Qualification and validation experience of equipment or systems

Day-To-Day Responsibilities:
  • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
  • Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
  • Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
  • Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
  • Provide expert support for investigations as well as new process development required to improve manufacturing operations.
  • Coordinate test method development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly requirements.
  • Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new process equipment.
  • Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
  • Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
  • Generate/author and own the Test Method documents.
  • 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
  • Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
  • Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
  • Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen
  • Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
  • Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
  • Collaborates with other functional leaders to ensure project success, momentum, and commitment
  • Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
  • Integrates partner/vendor timelines with Amgen timelines as appropriate

Employee Value Proposition:
The person in this position will work to build test methods to determine if products are ready to go out to market. This team focuses mostly on device design, failure analysis.


Red Flags:
  • No B.S. or M.S. in Mechanical Engineering, Biomechanical, Biomedical, Bioengineering or Materials Science
  • No Technical writing experience.
  • No communication skills
  • No statistical experience

Interview Process:
One 30 min phone screen followed by one 1-hour video interview with broader engineering team.

 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.



 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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