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POSITION SUMMARY:

The Senior Engineer holds a crucial role within Global MSAT and will partner with R& D, Procurement and Make Functions, New Product Introduction, and Value Chain Management teams, as well as external partners, such as suppliers, to develop and implement robust manufacturing process design solutions for Primary Packaging Components Glass Containers ( Cartridges, Syringes) and Closure Systems (Stoppers, Cap, Plungers) to meet the emerging and future needs of the portfolio.

As a Senior Engineer, you will be responsible for the technical development, Life cycle management & manufacturing readiness and implementation of primary Packaging components and its interdependencies to the Devices into the Johnson & Johnson manufacturing network.

You will play a pivotal role in the development, life cycle and manufacturing of medical devices for drug-device combination products. You will lead and contribute to complex projects, ensuring the successful design, development, validation, and transfer of medical devices to support the global device platform ensuring adequate capacity and capability for supply of medical devices used in drug/device combo products.

You have a deep understanding of drug product primary packaging manufacturing, glass cartridges as well as rubber and plastic molding development. Your comprehensive technical expertise with advanced knowledge in the application of engineering principles, world‐class manufacturing techniques, statistical analysis will enable you to independently plan, organize and direct programs of significant scope and complexity.

PRINCIPAL RESPONSIBILITIES:

• Provide subject matter expertise to the manufacturing strategy, control strategy of primary packaging components with the supplier and embed them into the manufacturing control strategy of the Make functions.
• Lead process design and characterization studies, primary packaging Life cycle management and major investigations and improvements plans
• Contribute to supplier selection process by providing technical leadership and assessments
• Partner with receiving sites to ensure voice of manufacturing is represented in product design (e.g., design for manufacturability)
• Partner with external suppliers to ensure component development processes lead to robust manufacturing processes
• Provide technical expertise to site personnel to adequately transfer the Primary packaging material for design and technology transfer activities
• Contribute to develop manufacturing process capacity scale-up for internal and external manufacturing

KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:

• Experience in communicating across various levels of an organization is required.
• Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
• Excellent organizational and planning skills, strong interpersonal, verbal, and written communications skills. Demonstrates strong collaboration with colleagues.
• Experience in primary packaging components (Syringe, vials, cartridge) is desired. Design for manufacturability and assembly experience is required.
• Plastic and metals materials and processing technologies is preferred, Knowledge & expertise in applying Combination Products cGMP regulations is preferred.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

• Can manage technical and quality discussions to resolve issues,
• Manages multiple products and/or teams simultaneously.

DEGREE:

• Master in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials.
• A minimum of 6 years’ experience in some aspects of medical device design, development, new product introduction and/or technical support

LANGUAGES:

• Fluent in English, German is a plus

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

• Based in Switzerland, in proximity to Schaffhausen or another JJ location
• Travel < 10%