Home Stellen in Singen (Hohentwiel) Takeda GmbH Process Engineer Drug Substance (f/m/d)

Process Engineer Drug Substance (f/m/d)


Job ID R0020369

Primary Accountabilities:

  • Providing process support for engineering, qualification and validation of new and existing vaccine manufacturing facilities / processes in compliance with global regulatory requirements
  • Providing ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing 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
  • 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

Your Profile:

  • A BS/MS in chemical / biochemical engineering or related field
  • Ideally 2 years experience (BS) or 1 year (MS) in support of start-up, tech transfer and sustaining cGMP commercial drug substance manufacturing process operations in vaccines or biopharmaceuticals
  • Demonstrate experience/ technical knowledge within drug substance manufacturing is required including up-stream (mammalian cell culture) and down stream /purification unit operations
  • Experience in virus production and purification of live virus is desirable
  • 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
  • Demonstrated experience providing engineering and/or process support of drug substance manufacturing operations to meet global regulatory requirements is required
  • Direct interaction / experience with regulatory agencies during inspections for licensing of commercial manufacturing operations is a plus
  • 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
  • Willingness to travel
  • Fluent in German and English

Infos zur Stelle
Singen (Hohentwiel)
Stelle teilen
Takeda GmbH

Takeda GmbH
Robert-Bosch-Straße 8
78224 Singen

Selina Wrzeszcz

Tel: 07531 84-5410