Principal Engineer DAP TLI

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /p pAs 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. /p h3Job Function /h3 pSupply Chain Engineering /p h3Job Sub Function /h3 pProcess Engineering /p h3Job Category /h3 pScientific/Technology /p h3All Job Posting Locations /h3 pAllschwil, Switzerland, Schaffhausen, Switzerland, Zug, Switzerland /p h3Job Description /h3 h3Principal Engineer, Device Packaging Technical Launch Integrator (TLI) (f/x/m) /h3 pEnabling 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. /p pWe are looking for an experienced colleague who combines strong bdevice and packaging technical expertise with project leadership and an end-to-end mindset /b. Together, we strive to bring innovative combination products and packaging solutions successfully into our commercial supply chain. /p pIn this role, you will work within the bLocal Launch team of the MSAT Biotherapeutics Platform /b. As a bDevice Packaging Technical Launch Integrator (TLI) /b, you will provide technical leadership for the transfer, industrialization, validation, and launch of device and packaging solutions at commercial scale. /p h3Key Responsibilities /h3 h3Device Packaging Technical Leadership /h3 ul liAct as the bMSAT Device Packaging technical lead /b for assigned new product introduction and technology transfer projects. /li liLead global and local cross-functional project teams and represent MSAT Device Packaging within the value chain team and project development teams. /li liProvide technical leadership across bdevice assembly, secondary packaging, labeling/artwork interfaces, and associated manufacturing processes /b. /li liPartner with RD, Supply Chain, Quality, Regulatory, Engineering, Procurement, manufacturing sites, and external suppliers to translate product and design requirements into robust commercial manufacturing solutions. /li liEnsure appropriate specifications, controls, and technical requirements are established for device components, packaging materials, and associated processes. /li /ul h3Design Transfer, Industrialization Validation /h3 ul liLead the bdesign and technology transfer /b of device and packaging solutions into the commercial manufacturing environment. /li liDrive development, implementation, scale-up, qualification, and validation of device assembly and packaging processes at commercial scale. /li liPartner closely with project and equipment engineers to ensure manufacturing equipment is appropriately designed, tested, installed, qualified, and ready for routine production. /li liLead technical problem solving and risk management throughout transfer, qualification, validation, and launch. /li liEnsure solutions are robust, manufacturable, compliant, and capable of supporting reliable commercial supply. /li /ul h3Launch Readiness Project Leadership /h3 ul liDrive Device Packaging activities from project initiation through btechnical transfer, PPQ/validation, regulatory submission readiness, launch, and handover to the receiving organization /b. /li liEstablish clear project plans, deliverables, risks, dependencies, and milestones for the Device Packaging workstream. /li liProactively identify technical and project risks and drive mitigation and escalation where required. /li liProvide regular updates to project stakeholders and sponsors through reports, presentations, governance meetings, and ad-hoc communication. /li liWork closely with the manufacturing-site organization to ensure successful project execution and operational readiness. /li liEnsure technical deliverables supporting health-authority submissions and launch readiness are completed on time and with the required quality. /li /ul h3Technical Documentation Compliance /h3 ul liDeliver a robust technical transfer documentation package in accordance with applicable bcombination product, device, packaging, and design-transfer procedures /b. /li liKey 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. /li liEnsure applicable requirements for Design Control, Risk Management, Purchasing Controls, Change Control, Qualification, Verification, and Validation are appropriately addressed. /li /ul h3Qualifications /h3 h3Education /h3 ul liBachelor’s or Master’s degree in Engineering, Science, or a related technical discipline. /li /ul h3Required Experience and Skills /h3 ul liAt least b10 years of relevant experience /b in device, packaging, manufacturing, engineering, technology transfer, project management, or RD, preferably within the pharmaceutical, combination-product, or medical-device industry. /li liStrong experience leading complex technical projects from initiation through transfer, validation, and commercial implementation. /li liDemonstrated ability to lead multifunctional teams in a global and cross-functional environment. /li liStrong technical understanding of bdevice assembly and/or pharmaceutical packaging processes /b , including their industrialization and validation. /li liAbility to translate product and design requirements into practical, robust commercial manufacturing solutions. /li liStrong communication, stakeholder management, and technical leadership skills. /li liComfortable working toward ambitious goals, navigating complexity, and solving challenging technical and organizational problems. /li liAbility to influence and drive decisions across functions and organizations without direct reporting relationships. /li /ul h3Preferred /h3 ul liExperience with combination products, medical devices, primary and secondary packaging, or device assembly. /li liKnowledge of applicable regulatory and quality-system requirements, including bDesign Control, Risk Management, Purchasing Controls, Change Control, Qualification, Verification, and Validation /b. /li liExperience working with external device/component suppliers and Contract Manufacturing Organizations is an advantage. /li liExperience with technical transfer and launch of new products into a GMP commercial manufacturing environment is preferred. /li /ul h3What’s in it for you? /h3 pAt Johnson Johnson, we recognize that bringing innovative medicines to patients requires diverse expertise, strong collaboration, and an environment where people can grow and contribute. /p pBased at one of our JJ Innovative Medicine sites, you will be part of a global team working across the US and Europe and collaborating with RD, Supply Chain, manufacturing sites, and external partners. The role provides significant exposure to our new product pipeline and opportunities for personal and professional development. /p pYou will have the flexibility to work from home up to 40% and may be requested to travel internationally up to 10%. /p pAt Johnson Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. /p h3Join us! /h3 h3Required Skills: /h3 h3Preferred Skills: /h3 pAgile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research /p #J-18808-Ljbffr