Senior/Principal Engineer, Combination Products and Drug Delivery Devices

Role Summary

Senior/Principal Engineer, Combination Products and Drug Delivery Devices responsible for providing project and technical leadership in the development, manufacturing, and lifecycle management of parenteral drug delivery systems. Acts as a subject matter expert, leading major technical transfer and validation projects related to new product development, launches, and lifecycle management, and collaborating with R&D for seamless technology transfer across internal and external networks.

Responsibilities

• Serve as Takeda‚Äôs expert on combination product development, technology transfer, manufacturing, and assembly processes and technologies.
• Lead activities in partnership with Pharmaceutical Sciences and/or Operating Units, including
  • Combination products and device manufacturing process development, characterization, and optimization‚Äîincluding fill/finish, assembly, and packaging.
  • Technology transfer to both contract manufacturing organizations (CMOs) and internal manufacturing facilities.
  • 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.
• Manage multiple projects within the Takeda portfolio, supporting both development and commercial Manufacturing Sciences Combination Products and Device Science activities.
• Implement strategies for continuous improvement in the manufacturing of commercial products and lifecycle management.
• Collaborate closely with R&D, Quality, Regulatory, Procurement, and External Supply Teams to support seamless device lifecycle management and supply continuity.
• Own and manage the end-to-end change control process.
• Act as the SME for the Takeda combination products and device manufacturing organization.
• Possess in-depth knowledge of combination products and device manufacturing technologies for injectable products‚Äîincluding PFS/vial fill finish, autoinjector, and needle safety device assembly and packaging.
• Demonstrate expertise in industry best practices and emerging technologies for combination product and device manufacturing, with experience leading innovation initiatives.
• Lead cross-functional teams and effectively influence key stakeholders‚Äîto drive alignment, decision-making, and resolution of complex issues.
• Champion the communication and implementation of innovative and emerging technologies for combination product and device manufacturing within Manufacturing Sciences.
• Independently make key decisions impacting the development and manufacturing of combination products and drug delivery devices.
• Engage actively with Product Operations, Quality, Regulatory, and External CMO Operations & Supply groups to maintain supply continuity for key Takeda products.
• Partner with manufacturing sites to ensure consistent application of best manufacturing practices across the Takeda network and facilitate process knowledge sharing for effective product management.
• Stay current with industry-leading technologies and manufacturing strategies.
• Drive and implement innovative technologies at manufacturing sites.
• Manage within a matrixed organizational structure across functional areas.
• Provide leadership for highly complex projects spanning multiple sites and products.
• Actively partner with local Technical Services lead to ensure consistent application of best manufacturing practices across Takeda network, ensuring process knowledge sharing across sites and functions.
• Maintain current industry leading technology knowledge, and regulatory strategies.
• Ability to drive and implement innovative technologies at manufacturing sites.
• Manage with a matrix of reporting lines and across functional areas.
• Provide leadership to drive highly complex projects that span multiple sites and products.

Qualifications

• 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.

Education

• Graduate degree as listed in Qualifications; PhD preferred.

Locations

AUT - Linz Campus (Plasmazentrum); Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time