Process Engineer Drug Substance (f/m/d)

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Job Description

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Process Engineer Drug Substance (f/m/d)

Join our thriving team as a Process Engineer Drug Substance in Manufacturing Science and Technology (MS&T), where you will play a pivotal role in supporting cGMP manufacturing and optimizing manufacturing processes. Leverage your expertise in cutting-edge technologies to contribute to the heart of vaccine production, ensuring the highest standards of quality and efficiency across our manufacturing sites

Your main responsibilities:

• Providing ongoing technical support for change control, deviation investigations and CAPA management as required during commercial manufacturing and development of products in VBU’s portfolio.
• Utilizing external and internal networks to identify resources and build partnerships in the areas of process technologies to drive best in class manufacturing operations.
• Providing process support for engineering, qualification, validation and cGxP manufacturing of new and existing vaccine manufacturing facilities / processes in compliance with global regulatory requirements.
• Supporting life cycle management projects and technology transfer from process development to cGMP manufacturing and site transfers of commercial manufacturing processes as required to meet global demand forecasts.
• Partnering with internal business partners to provide technical input for process fit assessments within existing manufacturing facilities and to define process requirements for new manufacturing facilities.
• Offering ongoing technical support for change control, deviation investigations, and CAPA management in commercial manufacturing and product development within VBU’s portfolio. Also, using internal and external networks to find resources and build partnerships in process technologies to enhance manufacturing operations.
• Supporting process trending and continued process verification (CPV) activities, which involve signal review and statistical analysis.

Your profile:

• MSin chemical / biochemical engineering, biology or equivalent with a minimum of 2 years of experience in cGMP manufacturing operations of biopharmaceuticals or vaccines or support of start-up or tech transfer of such manufacturing to meet global regulatory requirements is required.
• Demonstrated experience within biological drug substance manufacturing or mammalian cell culture and down-streaming unit operations. Experience in virus production and purification of live virus is desirable.
• Experience in writing of technical documents, including manufacturing documents, validation documents, protocols, and reports.
• The Process Engineer will be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of commercial vaccine manufacturing.
• Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment.  Ability to support cross-functional technical teams, serve as a partner and influence others.
• Very good German and English skills.
• Experience with regulatory agencies during inspections for licensing of commercial manufacturing operations is a plus.

In this position you will report to the Associate Director Drug Substance.

Your benefits:

• 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

• Travel allowance

• 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.

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