Senior/principal Engineer, Combination Products And Drug Delivery Devices

Senior/Principal Engineer, Combination Products And Drug Delivery Devices

As a Senior/Principal Engineer, Combination Products And Drug Delivery Devices, you will provide project and technical leadership in the development, manufacturing, and lifecycle management of parenteral drug delivery systems. Serving as a subject matter expert (SME), you will lead major technical transfer and validation projects related to new product development, launches, and lifecycle management. You will work closely with R&D teams to ensure the development and seamless technology transfer of combination products for successful manufacturing across internal and external networks. Additionally, you will drive optimization of manufacturing processes and lead or support deviations and investigations.

Your contributions will include:

• Serving as Takeda's expert on combination product development, technology transfer, manufacturing, and assembly processes and technologies.
• Leading activities in partnership with Pharmaceutical Sciences and/or Operating Units, including combination products and device manufacturing process development, characterization, and optimization—including fill/finish, assembly, and packaging.
• Managing key internal partner and external vendor relationships.
• Providing technical support to rapid response teams to address urgent challenges and maintain operational and supply continuity.
• Managing multiple projects within the Takeda portfolio, supporting both development and commercial Manufacturing Sciences Combination Products and Device Science activities.
• Implementing strategies for continuous improvement in the manufacturing of commercial products and lifecycle management.
• Collaborating closely with R&D, Quality, Regulatory, Procurement, and External Supply Teams to support seamless device lifecycle management and supply continuity.
• Owning and managing the end-to-end change control process.
• Acting as the SME for the Takeda combination products and device manufacturing organization.
• Possessing in-depth knowledge of combination products and device manufacturing technologies for injectable products—including PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging.
• Demonstrating expertise in industry best practices and emerging technologies for combination product and device manufacturing, with experience leading innovation initiatives.
• Leading cross-functional teams and effectively influencing key stakeholders—including Pharmaceutical Sciences, Plasma Derived Therapies R&D, GMS Operating Units, and CMOs—to drive alignment, decision-making, and resolution of complex issues.
• Championing the communication and implementation of innovative and emerging technologies for combination product and device manufacturing within Manufacturing Sciences.
• Independently making key decisions impacting the development and manufacturing of combination products and drug delivery devices.
• Engaging actively with Product Operations, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity for key Takeda products.
• Partnering with manufacturing sites to ensure consistent application of best manufacturing practices across the Takeda network and facilitating process knowledge sharing for effective product management.
• Staying current with industry-leading technologies and manufacturing strategies.
• Driving and implementing innovative technologies at manufacturing sites.
• Managing within a matrixed organizational structure across functional areas.
• Providing leadership for highly complex projects spanning multiple sites and products.
• Actively partnering with local Technical Services lead to ensure consistent application of best manufacturing practices across Takeda network. Ensures process knowledge sharing across sites and functions for effective management of products.
• Maintaining current industry leading technology knowledge, and regulatory strategies.
• Ability to drive and implement innovative technologies at manufacturing sites.
• Manages with a matrix of reporting lines and across functional areas.
• Provides leadership to drive highly complex projects that span multiple sites and products.

What you bring to Takeda:

• Graduate degree in Mechanical, Biomedical Engineering, Material Science, or a related discipline, with 10+ years (Principal Engineer) or 5+ years (Senior Engineer) of relevant industrial experience (PhD preferred).
• Prior experience as a team lead in a matrixed environment involving combination product and device development and manufacturing.
• Strong understanding of design control and regulatory requirements (FDA, EMA, ISO, USP) for combination products and devices.
• Experience in the development and manufacturing of parenteral drug delivery systems, including PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging—is highly preferred.
• Self-motivated with strong interpersonal skills; adept at analyzing and solving complex problems through innovative thinking and practical experience.
• Demonstrated ability to work independently and collaboratively within cross-functional teams.
• Skilled at navigating ambiguity and driving results in a dynamic, matrixed environment.
• Strategic, enterprise-minded thinker who finds innovative ways to serve patients and build trust.
• Capable of inspiring and enabling people in a collaborative environment.
• Focused on key priorities to deliver superior results.
• Dedicated to elevating capabilities for present and future needs.

Locations: AUT - Linz Campus (Plasmazentrum) Cambridge, MA