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Senior Process Engineer Drug Product (f/m/d)

Senior Process Engineer Drug Product (f/m/d)

location78224 Singen (Hohentwiel), Deutschland
VeröffentlichtVeröffentlicht: 6.12.2024
Ingenieure / Technik
Vollzeit

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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

Senior Process Engineer Drug Product (f/m/d)

As a Senior Process Engineer, you will play a key role in managing the technical aspects of global drug product manufacturing within the Vaccines Technical Operations group. You will drive continuous process improvements across Takeda's commercial sites, ensuring the implementation of advanced technologies and process harmonization. You will provide technical leadership for resolving complex product line issues and managing major projects, serving as the primary technical interface between Technical Operations and drug product manufacturing sites.

How you will contribute:

  • Lead global drug product manufacturing within Vaccines Technical Operations, driving process improvements across Takeda's commercial sites.

  • Implement advanced technologies and harmonize processes, providing technical leadership for resolving product line issues and managing major projects.

  • Independently serve as the primary technical interface for troubleshooting, Change Controls, investigations, CAPAs, and regulatory inspections.

  • Leads technology transfers, risk assessments, and innovative solutions while collaborating with Development and Site Operations teams.

  • Take responsibility for the engineering, qualification, and validation of vaccine manufacturing processes, ensuring full compliance with global regulatory standards and Takeda’s quality expectations.
  • Influence stakeholders and ensure successful execution of technical activities across the organization.

  • Mentor and support the development of team members within the MST team, fostering growth and collaboration.

  • Deputize for the direct line manager as needed, ensuring effective leadership.

In this position you will report to the Manager Vaccines MS&T Drug Product.

What you bring to Takeda:

  • Bachelor’s or master’s in chemical, Biochemical, Biotechnology, Biopharmaceutical Engineering, or related fields.

  • Minimum 8 years of experience in GMP drug product manufacturing, preferably in biopharmaceuticals; vaccine and external manufacturing.

  • Strong technical writing skills and expertise in single-use systems, aseptic filling, lyophilization, and visual inspection.

  • Experience in Technology Transfers, Quality Systems (Change Control, Risk Assessment), and regulatory processes, including direct interaction with regulatory agencies during inspections.

  • Experience collaborating with external parties and CMOs is a plus.

  • Ability to manage diverse projects, from technical to administrative, with strong collaboration skills in a matrix environment.

  • Willingness to travel and excellent communication skills in English; German proficiency is a plus.

What we offer you:

  • Attractive and competitive salary according to collective bargaining agreement

  • Open-minded and modern working environment

  • Hybrid working model

  • 30 vacation days

  • Company pension plan

  • Further education and training

  • Commuting allowance for public transport

  • Attractive Relocation Package including brokerage fees

  • Subsidized canteen

  • Subsidized sports programs

  • Disability insurance

  • Supplementary nursing care insurance

  • Long-term account with various possible uses

  • Employee discounts

  • Employee Stock Purchase Plan

  • Group accident insurance

  • Employee Referral Program

  • Deferred compensation as desired

  • Future amount

  • Global Wellbeing Program

  • Interactive online courses for employees' children

  • Employee Recognition Program

About Us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.

In Singen, around 1,200 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 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.

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

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