Job Title:   Engineer, GMP Test Methods Medical Device – (JP10960)
Location: Thousand Oaks, CA. 91320
Employment Type:  Contract
Business Unit: Physical Testing Systems Development
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 10/25/22
Notes: Only qualified candidates need apply.

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: Physical Science and Engineering CCI (Container Closure Integrity), testing of syringes in the Device and Packaging Engineering lab. Research & Development. Lab Experiment. 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. Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for Container Closure Integrity (CCI). Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for CCI systems. Perform field evaluations of existing systems and provide engineering design recommendations.

Top Must Have Skills:

• Bachelors, must have (Engineering or Biomedical,STEM)
• Must have experience in work or laboratory settings (will consider new grads)
• Experience with Statistical Software, perferred
• SolidWorks - or Computer Aided Design (cad) experience, perferred
• MSA experience (Measurement System Analysis) training is a plus - Our team uses this for measuring the abilities of the processes we design.

Day to Day Responsibilities:

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Provide support of senior staff for delivery of Projects.
• 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.

Basic Qualifications:
Previous work experience is a plus. SolidWorks 3D CAD FEA. Minitab. JMP. Experience working in team.

Red Flags:

• No Bachelors Degree
• Degree not related to STEM or Biomedical
• No mechanical aptitude - no experience using tools, building or designing and assembly or disassembly of equipment/components.
• No CAD use.

Interview process:

• Phone screening

• Webex 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.