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Engineer - Biotech Combination Product (JP7697)

Thousand Oaks, Ca · Biotech/Pharmaceutical

Job Title:  Engineer - Biotech Combination Product (JP7697)
Location: Thousand Oaks, CA 
Employment Type: Contract
Duration: 18 months with likely extensions or conversion for FTE
Business Unit: CCI Testing
Job posting date: 9/16/20.
3 Key Consulting is hiring an  Engineer  for a consulting engagement with our client, a leading global bio-pharmaceutical company.
Note: Candidates will be working on site 2-3 days a week during COVID-19.
Job Summary:
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, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Responsibilities may 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 the 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 the company
  • Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership  
Top Must have Skill Sets:
  • Technical writing skills (1-2 years of experience)
  • CAD experience (1-2 years of experience)
  • Statistical experience (JMP) (1-2 years of experience)
  • Soft skills:  verbal and written communication skills, detail oriented, working within a team environment.
Employee Value Proposition:
Growing their skill set, working at a great biotech/pharma company.
Red Flags:
Unable to work in a team.  

Interview Process:
Phone 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.
3KC Talent Acquisition Team

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