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Staff Engineer
Company: Johnson & Johnson
Location: Lexington, MA
Employment Type: Full Time
Date Posted: 10/02/2021
Expire Date: 03/16/2022
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Engineering, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Medical
Job Description
Staff Engineer

Janssen Research and Development, LLC, a member of Johnson and Johnson's Family of Companies, is recruiting for a Staff Engineer, which will be located in Lexington, MA.  The Staff Engineer, Primary Container & Device (PC&D), will support the development of innovative drug delivery devices and combination products for new therapeutics at Janssen.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Research & Development, LLC, is part of the Janssen Pharmaceutical Companies.

Job Duties and Responsibilities

The Staff Engineer works with Quality, Regulatory, Commercial, Formulation, Drug Product Development (DPD), Analytical Development (AD), Sourcing, other members of PC&D and other business partners to understand device/combination requirements, investigating suitable device/combination options (considering in sequence Janssen platform devices, other commercially available devices, and devices requiring significant development), to coordinate the development of an appropriate device strategy for the program and to execute the strategy. They work directly with internal or external manufacturers to ensure manufacture of combination product clinical trial materials to meet the clinical demand schedule, and manufacture of development devices and combination devices to meet the needs of the overall product development plan.

Principal responsibilities:

  • Apply phase-appropriate design control processes to develop products from clinical phases to commercial launch.
  • Drive the manufacture of combination products to meet the clinical demand schedule and participate in the clinical trial material planning meeting.
  • Drive the development and manufacture of combination products as needed to advance the program and meet design control and CMC stage gate processes as applicable.

As part of these responsibilities, the Staff Engineer:

  • Is expected to be familiar with available drug delivery devices and external device partners and manufacturers.
  • Works directly with external suppliers and manufacturers to develop, test and manufacture devices/combination products, and ensure their availability for testing, clinical studies, and commercial launch.
  • Works closely with Drug Product Development (DPD) and Analytical Development (AD) counterparts as required to support combination product development.
  • Works with external manufacturers, Janssen Supply Chain (JSC) and/or Clinical Supply Chain (CSC) to coordinate manufacturing and supply for clinical studies and commercialization.
  • Supports Human Factors testing as needed to evaluate product usability.
  • Writes documents required by the design control process, and ensures that these documents are entered into and approved in the document control system, as appropriate.

  • A bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Plastics Engineering or similar is required
  • A minimum of 6 years of related experience is required.
  • Drug development or medical device development is preferred.
  • Experience with combination products preferred.
  • Experience with thermoplastic and silicone extrusion processes required.
  • GMP experience preferred.
  • Experience applying the design control process is highly preferred
  • Excellent verbal and written communications skills, with technical or cross-functional audiences.
  • Familiarity with statistical software packages such as Minitab or JMP a plus.
  • Familiarity with computer aided drawing software such as SolidWorks a plus.
  • Strong interpersonal skills.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Massachusetts-Lexington-113 Hartwell Ave
Janssen Research & Development, LLC (6084)
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