"Alerted.org

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Title: Senior/Principal Engineer, Combination Products and Drug Delivery Devices

About the role:

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.

How will you contribute:

+ Serve as Takeda’s 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—including 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—including 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—including Pharmaceutical Sciences, Plasma Derived Therapies R&D, GMS Operating Units, and CMOs—to 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. Ensures process knowledge sharing across sites and functions for effective management of products.

+ Maintain 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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time