Job Title: Engineer, Biotech Medical Device (JP9592) Location:Thousand Oaks, CA Employment Type: Contract Business Unit: Final Product Technologies Duration: 18 months with likely extensions Job posting date 12/27/2021 Note: 3 days onsite, 2 days remote (varies on projects), Local candidate needed.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
The Engineer 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.
Master's Degree OR
Bachelor's Degree and 2 years of engineering/scientific experience OR
Associate's degree and 6 years of engineering/scientific experience OR
High school diploma/GED and 8 years of engineering/scientific experience.
M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
Excellent written and verbal communication skills
Ability to work in a highly matrixed team environment
2 years of experience in the biotechnology/pharmaceutical industry
2 years of experience in equipment, method, and mechanical design
Technical writing experience
Experience with SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience utilizing Minitab (or other statistical software packages)
Experience with machine controls (PLC, HMI) and vision systems
Top Must have Skill Sets:
Design and Prototyping
Experience in validation or related industry experience
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.
Generate/author the Test Method documents.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
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
Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership.
Red Flags: No CAD experience No work or school engineering/scientific experience
Interview Process: 30 minute phone interview
1 hr video 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.