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Job Description:

Janssen Supply Group, LLC, a member of the Johnson & Johnson Family of Companies is recruiting for a Device & Primary Pack Engineer to join our Small Molecules Packaging & Device Team, within the MSAT organization! This position' s primary location is in Beerse, Belgium.

Are you interested in joining a global and diverse team that is helping improve patient care and drive innovation? At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Apply today for this exciting opening!

Device and Packaging solutions are becoming an increasingly meaningful component in delivering innovative medicines to our patients. The Device & Primary Pack Engineer will be working in a multi-functional setting, responsible for the lifecycle engineering and technical support for the device constituent for combination products in the JSC network. They will lead and support tech transfers, product and process quality improvement and reliability projects, and be the key point of contact to site and external operations, suppliers and quality for their area of responsibility.

Key Responsibilities:

• Device & primary packaging engineering including process engineering, product engineering and support to site or external manufacturing network as necessary
• Serve as Device design owner for one or more products in the JSC portfolio and conduct design controls, maintain design history file
• Provide technical aspects of capacity scale-up to support global demand for the product lifecycle and qualify additional capacity for sub-assembly and assembly processes per manufacturing network strategies
• Develop and qualify additional supplier capacity (multi-cavitation for plastic molded components, other process technologies as necessary) per quality systems requirements
• Support drug product primary packaging and device assembly sites in solving technical issues as vital
• Lead design change controls for devices. Perform change control activities for combination product device & primary pack (supplier, process and other changes)
• Lead or support projects as necessary to address issues with customer satisfaction, quality, manufacturing improvements and cost reductions
• Provide audit support where required
• Lead or contribute to the improvement of processes and quality systems in support of combination products and the device constituents of combination products

Qualifications:

Education:

• Minimum of a Bachelor' s/University or equivalent degree in Engineering or Science

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience in some aspects of medical device design, development, new product introduction, and/or technical support
• Proven track record to perform root cause investigations and write technical documents
• Shown ability to responds to complex inquiries from all levels of employees or external sources, strong communications and collaboration skills
• Excellent organizational and planning skills, able to balance multiple priorities
• Strong interpersonal and decision-making skills, ability to operate in a dynamic environment with professionalism and confidentiality
• Intermediate to advanced computer skills, including document management systems, word processing, spreadsheets, project planning, and basic database applications

Preferred:

• Skills with Medical Device Design Controls, Change Control, CAPA, Complaint Handling, Risk Management Tools, FMEA, and Process Validation, and/or ISO 13485, ISO 14971, EU MDR, ICH.
• Ability to use statistical techniques when analyzing the data and make rational and logical decision based on that analysis
• Project management skills and/or certification
• Experience supporting and working in a complex organization and communicating across many levels of such organization

Other:

• Requires proficiency in English (oral and written); proficiency in Dutch is preferred
• May require up to 10% domestic and/or international travel