Process Validation Engineer (f/m/d)

at  Takeda Pharmaceutical

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JOB DESCRIPTION

Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a
Process Validation Engineer (f/m/d)
The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in Singen and CMOs. The process validation activities related to the Singen & CMO manufacturing site include, but are not limited to, the following areas.

ABOUT US:

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet.
In Singen, around 1,300 employees specialize in the production of liquid, semi-solid and freeze-dried medicines. Singen is the only production site in the global Takeda network for the manufacture of our new dengue fever vaccine. Takeda Singen is a regionally significant employer and has been awarded the independent Top Employer certificate several years in a row. The site is characterized by its high level of diversity (e.g., more than 55 nationalities and over 40% of leaders are women), its long company history and its excellent development opportunities. The town of Singen (Hohentwiel) is located on the beautiful Lake Constance in Baden-Württemberg with a view of the Alps and close proximity to France, Liechtenstein, Austria, and Switzerland.

• Validation subject matter expert to conceive, design and direct the execution of validation/technical shared services projects in support of VBU
• Authoring process validation documentation for Lifecycle Process Validation
• Oversight and approval of process validation activities, as well as perform data analysis and compilation of data and results into summary and final reports
• Align manufacturing processes with executed validation
• Participate in regulatory inspections and author, review filing, submission documents
• Identify opportunities for continuous improvements, participate in the deployment of best practices, represent process validation at Singen &CMO Work System meetings and support and maintain the process validation communications board and community of practice
• Establish, support and direct collaborative projects with other VBU functions for example CMC, External Manufacturing, PO, Quality and External Partners CMOs to generate and execute process and product technology transfers and the associated qualification and validation activities