Sr Device Lifecycle Senior Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Supply Chain Engineering

Job Sub Function:

Packaging Design Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium, Schaffhausen, Switzerland

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.
 

Key Responsibilities

• 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.
   

Qualifications & Skills

• 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

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