Principal Engineer DAP TLI

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Enabling access to and delivering our new product pipeline to customers and patients globally is a high priority for Johnson & Johnson Innovative Medicine and the Schaffhausen Launch & Grow site.

We are looking for an experienced colleague who combines strong device and packaging technical expertise with project leadership and an end-to-end mindset. Together, we strive to bring innovative combination products and packaging solutions successfully into our commercial supply chain.

In this role, you will work within the Local Launch team of the MSAT Biotherapeutics Platform. As a Device & Packaging Technical Launch Integrator (TLI), you will provide technical leadership for the transfer, industrialization, validation, and launch of device and packaging solutions at commercial scale.

• Act as the MSAT Device & Packaging technical lead for assigned new product introduction and technology transfer projects.
• Lead global and local cross-functional project teams and represent MSAT Device & Packaging within the value chain team and project development teams.
• Provide technical leadership across device assembly, secondary packaging, labeling/artwork interfaces, and associated manufacturing processes.
• Partner with R&D, Supply Chain, Quality, Regulatory, Engineering, Procurement, manufacturing sites, and external suppliers to translate product and design requirements into robust commercial manufacturing solutions.
• Ensure appropriate specifications, controls, and technical requirements are established for device components, packaging materials, and associated processes.
  

• Lead the design and technology transfer of device and packaging solutions into the commercial manufacturing environment.
• Drive development, implementation, scale-up, qualification, and validation of device assembly and packaging processes at commercial scale.
• Partner closely with project and equipment engineers to ensure manufacturing equipment is appropriately designed, tested, installed, qualified, and ready for routine production.
• Lead technical problem solving and risk management throughout transfer, qualification, validation, and launch.
• Ensure solutions are robust, manufacturable, compliant, and capable of supporting reliable commercial supply.

• Drive Device & Packaging activities from project initiation through technical transfer, PPQ/validation, regulatory submission readiness, launch, and handover to the receiving organization.
• Establish clear project plans, deliverables, risks, dependencies, and milestones for the Device & Packaging workstream.
• Proactively identify technical and project risks and drive mitigation and escalation where required.
• Provide regular updates to project stakeholders and sponsors through reports, presentations, governance meetings, and ad-hoc communication.
• Work closely with the manufacturing-site organization to ensure successful project execution and operational readiness.
• Ensure technical deliverables supporting health-authority submissions and launch readiness are completed on time and with the required quality.
  

• Deliver a robust technical transfer documentation package in accordance with applicable combination product, device, packaging, and design-transfer procedures.
• Key deliverables may include design transfer plans and reports, control strategies, risk assessments/FMEAs, specifications, equipment qualification, process validation, distribution testing, procedures, protocols, data analysis, and technical summary reports.
• Ensure applicable requirements for Design Control, Risk Management, Purchasing Controls, Change Control, Qualification, Verification, and Validation are appropriately addressed.
  

• Bachelor’s or Master’s degree in Engineering, Science, or a related technical discipline.
  

• At least 10 years of relevant experience in device, packaging, manufacturing, engineering, technology transfer, project management, or R&D, preferably within the pharmaceutical, combination-product, or medical-device industry.
• Strong experience leading complex technical projects from initiation through transfer, validation, and commercial implementation.
• Demonstrated ability to lead multifunctional teams in a global and cross-functional environment.
• Strong technical understanding of device assembly and/or pharmaceutical packaging processes, including their industrialization and validation.
• Ability to translate product and design requirements into practical, robust commercial manufacturing solutions.
• Strong communication, stakeholder management, and technical leadership skills.
• Comfortable working toward ambitious goals, navigating complexity, and solving challenging technical and organizational problems.
• Ability to influence and drive decisions across functions and organizations without direct reporting relationships.
  

• Experience with combination products, medical devices, primary and secondary packaging, or device assembly.
• Knowledge of applicable regulatory and quality-system requirements, including Design Control, Risk Management, Purchasing Controls, Change Control, Qualification, Verification, and Validation.
• Experience working with external device/component suppliers and Contract Manufacturing Organizations is an advantage.
• Experience with technical transfer and launch of new products into a GMP commercial manufacturing environment is preferred.
  

At Johnson & Johnson, we recognize that bringing innovative medicines to patients requires diverse expertise, strong collaboration, and an environment where people can grow and contribute.

Based at one of our J&J Innovative Medicine sites, you will be part of a global team working across the US and Europe and collaborating with R&D, Supply Chain, manufacturing sites, and external partners. The role provides significant exposure to our new product pipeline and opportunities for personal and professional development.

You will have the flexibility to work from home up to 40% and may be requested to travel internationally up to 10%.

At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity.