Process Engineer (m/f/d)

Responsibilities

• Support development and execution of the technology transfer program for new product introduction
• Collaborate with teams and stakeholders to create and maintain GMP documents, including risk assessments, change controls, batch records, sampling plans, and Bills of Material (BOM)
• Maintain and update information from Development using digital tools such as COMET, SAP, MES, and DeltaV
• Manage schedules for new program introductions ensuring timely and accurate execution of tasks
• Represent Technology Transfer within various cross-functional teams and contribute actively

Profile

• Degree in a relevant scientific or technical field
• Relevant, in-depth experience in pharmaceutical or biotech industry environments
• Familiarity with Unit Operations in monoclonal antibody (mAb) manufacturing
• Basic knowledge of project management principles
• Proficient in preparing and transcribing manufacturing documents such as BOMs, batch sheets, and DeltaV documentation

Benefits

• Demonstrated ability to act as a change champion to foster innovation, digitization, and new ways of working
• Experience supporting rapid product launch strategies in a multi-product manufacturing environment
• Prior involvement with continuous and fed-batch process technology transfer