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Principal Engineer, DAP, TLI
Johnson & Johnson. Act as the MSAT Device & Packaging technical lead for assigned new product introduction and technology transfer projects .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading device and packaging technical projects, ensuring successful technology transfer and commercial implementation while adhering to regulatory standards. Proficient in managing cross-functional teams and driving project deliverables in a global environment.
Highest-signal resume keywords
Device Assembly ProcessesPharmaceutical Packaging ProcessesTechnical Project ManagementRisk ManagementGMP Commercial Manufacturing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical LeadershipProcess ValidationDesign ControlChange ControlQualificationVerificationFMEAData AnalysisSpecification DevelopmentTechnical Transfer Documentation
Soft Skills
Stakeholder ManagementCommunicationInfluencing SkillsTeam Leadership
Industry Keywords
New Product IntroductionTechnology TransferCross-Functional TeamsCombination ProductsContract Manufacturing OrganizationsRegulatory Submission Readiness
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- 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 value chain 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
- Establish specifications, controls, and technical requirements for device components, packaging materials, and associated processes
- Lead design and technology transfer of device and packaging solutions into commercial manufacturing
- Drive development, implementation, scale-up, qualification, and validation of device assembly and packaging processes at commercial scale
- Ensure manufacturing equipment is designed, tested, installed, qualified, and ready for routine production
- Lead technical problem solving and risk management throughout transfer, qualification, validation, and launch
- Drive Device & Packaging activities from project initiation through technical transfer, PPQ/validation, regulatory submission readiness, launch, and handover
- Establish project plans, deliverables, risks, dependencies, and milestones for the Device & Packaging workstream
- Provide updates to stakeholders and sponsors through reports, presentations, governance meetings, and ad-hoc communication
- Ensure technical deliverables supporting health-authority submissions and launch readiness are completed on time and to required quality
- Deliver technical transfer documentation, including 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 Design Control, Risk Management, Purchasing Controls, Change Control, Qualification, Verification, and Validation requirements are addressed
Requirements
What you’ll need- 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
- 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 industrialization and validation
- Ability to translate product and design requirements into practical, robust commercial manufacturing solutions
- Strong communication, stakeholder management, and technical leadership skills
- Ability to influence and drive decisions across functions and organizations without direct reporting relationships
- Preferred experience with combination products, medical devices, primary and secondary packaging, or device assembly
- Knowledge of 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
- May be requested to travel internationally up to 10%
Benefits
Comp & perks- Hybrid work arrangement with flexibility to work from home up to 40%
- Opportunities for personal and professional development
- International travel opportunities up to 10%