SENIOR PRINC. ENGINEER PRIMARY PACKAGING MATERIAL AND CLOSURE SYSTEMS

The Senior principal Engineer will partner with Suppliers, R&D, Procurement and Make Functions, New Product Introduction, and Value Chain Management teams, as well as external partners to develop and implement robust manufacturing process design solutions for Primary Packaging Components Glass Containers (Vial, Cartridges, Syringes) and Closure Systems (Stoppers, Cap, Plungers) to meet the emerging and future needs of the portfolio.
As a Senior Principal 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 and vial manufacturing 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.
Recognized as a Subject Matter Expert (SME) in vials, cartridges, syringes and plastic and rubber components, you will share your knowledge and expertise with colleagues, fostering a culture of innovation and excellence within our organization.
PRINCIPAL RESPONSIBILITIES.
• Lead primary packaging Life cycle management, • 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 • Lead major investigations and improvements plans • Lead supplier-initiated change management • 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.
., 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 • Lead technical aspects of capacity scale‐up to support global demand for the product life‐cycle at the suppliers • Execute Changes according to the change control procedure, act as change owner, assessor or action item owner Qualifications KNOWLEDGE SKILL AND ABILITY REQUIREMENTS.
• Glass Manufacturing & finishing • Molded components Manufacturing and finishing • The ability to interpret engineering drawings is required.
• Financial analysis and business case development is also required for this position.
• Organizational and planning skills will also be required for this role.
• process design and development or equipment development and implementation.
• Experience with process validation and statistical process control.
• Product design experience are preferred.
• Design for manufacturability and assembly experience is required.
• Position requires project management skills, as well as interpersonal communication skills.
• Candidates are also required to possess experience with quality systems and regulatory requirements.
• Proven ability to perform root cause investigations and write technical documents is required.
• Excellent organizational and planning skills, strong interpersonal, verbal, and written communications skills.
Demonstrates strong collaboration with colleagues.
• Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
• Plastic and metals materials and processing technologies is preferred, Knowledge & expertise in applying Combination Products cGMP regulations is preferred.
• Experience in communicating across many levels of an organization is preferred.
Financial analysis, business planning and business case development.
• The ability to use statistical techniques when analyzing data and make rational and logical decision based on that analysis.
Six-Sigma certification is a plus.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS • Can manage technical and quality discussions to resolve issues, • Manages multiple products and/or teams simultaneously.
• Six Sigma Black Belt Certification preferred DEGREE.
• Master in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials.
• A minimum of 12 years’ experience in some aspects of medical device design, development, new product introduction and/or technical support LANGUAGES.
• Fluent in native language German (or Flemish) with bi-lingual in English, ability to speak, present and/or respond before groups of customers, employees, health authorities/regulatory agencies, clients.
SPECIFIC SYSTEMS.
• Demonstrated experience in complying with one or more of the following.
FDA CFR part , and 820.
• Demonstrated experience with FDA regulated Design Control, Change Control, CAPA, and Complaint Handling and/or ISO , Medical devices.
• Proven skills with Change Control, CAPA, Complaint Handling, Risk Management Tools, FMEA, FMECA and others.
Engineering drawing interpretation capability, process validation experience.