Stellenangebot:
Process Engineer Drug Substance (f/m/d)

Stellenbeschreibung

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