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Location

Singen (Hohentwiel) | Germany

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Job description

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 and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 Engineer Drug Product (m/f/d)

In this role you will work in an international team on exciting technical topics related to the global production of vaccines

Your main responsibilities:

• Manage technical aspects related to global drug product manufacturing within the Vaccines Technical Operations scope.
• Drive continuous improvement initiatives for current and upcoming commercial manufacturing sites in the global Takeda vaccines manufacturing network.
• Initiate and oversee change both internally and externally, ensuring the implementation and maintenance of state-of-the-art technology and harmonization of cross-site processes.
• Provide technical leadership in resolving product line-related technical issues and major technical projects within Technical Operations.
• Offer technical oversight, troubleshooting, and support for activities across the vaccines manufacturing network.
• Act as the primary interface on technical matters between Technical Operations and drug product manufacturer sites.
• Lead the resolution of technical issues related to Change Controls, investigations, and CAPAs, supporting Health Authority Inspections.
• Collaborate with Development and Site Operations & Engineering Teams for process/product technology transfers to meet strategic growth initiatives.
• Coordinate and manage risk assessments, developing innovative solutions to complex issues requiring a high degree of ingenuity and creativity.
• Provide process support for the engineering, qualification, and validation of new and existing vaccine drug product manufacturing facilities/processes, including fill finish and visual inspection, in compliance with global regulatory requirements.
• Support technology transfer from process development to cGMP manufacturing and site transfers of commercial manufacturing processes, ensuring alignment with global demand forecasts.

Your profile:

• Bachelor's or Master's degree in Chemical, Biochemical, Biotechnology, Biopharmaceutical Engineering, or related field.
• 2-5 years (Bachelor's) or 1-4 years (Master's) experience in cGMP commercial drug product manufacturing in biopharmaceuticals.
• Proficient in Quality roles and use of Quality Management tools.
• Advantageous to have experience in vaccines and external manufacturing.
• Scientific and technical expertise in single-use materials, formulation processes, aseptic filling, isolator technology, validation, lyophilization, and visual inspection.
• Highly flexible for diverse projects and tasks, from complex topics to administrative duties.
• Proven ability to collaborate effectively in a matrix environment with internal teams and external partners.
• Direct interaction or experience with regulatory agencies is a plus.
• Willingness to travel as needed.
• Strong professional communication skills.
• Ability to work independently with excellent organizational skills.
• Excellent command of English; knowledge of German is a plus.

In this position you will report to the Associate Director, Technical Operations VBU.

Your benefits:

• Attractive and competitive salary

• Open-minded and modern working environment

• Hybrid working model

• 30 vacation days

• Company pension plan

• Further education and training

• Travel allowance for public transport

• Subsidized canteen

• Subsidized sports programs

• Disability insurance

• Supplementary nursing care insurance

• Long-term account

• Employee discounts

• Employee Stock Purchase Plan

• Employee Referral Program

• Deferred compensation as desired

• Future amount

• Global Wellbeing Program

• Childcare

• Employee Recognition Program

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 1,000 employees specialize in the production of liquid, semi-solid and freeze-dried pharmaceuticals. In November 2019, we inaugurated our first dengue vaccine factory worldwide here. Singen is located at the beautiful Lake Constance in Baden-Württemberg.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time #J-18808-Ljbffr

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Job tags

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Salary