Sr Device Lifecycle Senior Engineer
Role details
Job location
Tech stack
Job description
The Device Lifecycle Senior Engineer supports the Device &Primary Container Value Optimization Team as part of Drug Product MSAT Organization. This position is based at the Beerse in Belgium or Schaffhausen, Switzerland location. MSAT is a supply chain division of the Johnson & Johnson Innovative Medicines (J&J). MSAT is a worldwide organization, working in close partnership with Manufacturing Technical Operations (MTO) and PCD Primary Container and Device Development (R&D) organizations. The primary focus of MSAT is to provide technical competence and manufacturing science & technologies to J&J's pharmaceutical environment and product portfolio. The device lifecycle Senior engineer is responsible for the ongoing lifecycle engineering and technical support for combination products in the J&J Supply Chain network., * Lead lifecycle management activities for delivery devices constitute.
- Assess and validate materials for pharmaceutical products, ensuring compatibility, protection, and safety.
- Provide technical support for change control, investigations, CAPA, and process improvements.
- Ensure compliance with cGMP and regulatory requirements (CFR Parts 3, 4, 11, 210, 211, 820).
- Support validation activities and production processes at suppliers and manufacturing sites.
- Collaborate with cross-functional teams to enable technology transfers and process scale-up.
- Drive sustainability initiatives and continuous improvement projects.
- Apply project management methodologies (FPX, Six Sigma) to optimize design and reduce cost of goods.
- Communicate project objectives and updates to stakeholders.
Requirements
Do you have experience in Packaging?, Do you have a Master's degree?, * Bachelor's degree in Engineering or related discipline (Packaging preferred); MS or MBA desirable.
- Experience in primary container engineering/design and pharmaceutical manufacturing processes.
- Knowledge of primary packaging equipment and validation requirements.
- Familiarity with container closure systems (glass syringes, vials, bottles, blisters).
- Understanding of temperature-controlled chain distribution for pharmaceuticals.
- Strong analytical skills with ability to interpret data and apply statistical techniques.
- Excellent communication and collaboration skills with internal and external stakeholders.
- Proven compliance expertise in FDA and ISO standards.
Core Competencies
- Technical Expertise: Deep understanding of container closure systems and packaging.
- Problem Solving: Ability to analyze complex issues and implement effective solutions.
- Project Management: Skilled in FPX and Six Sigma methodologies.
- Collaboration: Strong interpersonal skills to work across global teams.
- Compliance: Adherence to regulatory standards and quality systems.
Additional Requirements
- Fluent in written and spoken English
- Systems: Change Control & Quality Management Systems, Document Management Systems, SAP/MRP
- Travel: Approximately 10%, based on project needs
Required Skills:
Preferred Skills: Coaching, Critical Thinking, Detail-Oriented, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Sustainability, Sustainable Packaging, Technologically Savvy, Validation Testing
