Process Validation Engineer (f/m/d) - Inklusiver Job 🦼 🦻 🦯

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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.

How you will contribute :

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

In this position you will report to the Senior Manager, Vaccines MS&T Validation.

What you bring to Takeda :

You have completed studies in the natural sciences field

Several years of experience in lifecycle process validation in manufacturing operations onsite and with CMOs for commercial and clinical manufacturing

Extended knowledge in Process Performance Qualification, Continued Process Verification, and risk management

Practical experience in vaccine production

Expertise in NPI, process and technology transfer

Excellent English and very good German language skills

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

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 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.

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