Senior Principal Process Engineer – Aseptic DP

Role Overview

• Accountable for the delivery of sophisticated engineering design, and construction solutions for manufacturing facilities, systems, and equipment.
• Support the discovery and development of new engineering standards for sophisticated technologies across the network.
• Collaborate with the Manufacturing Technology (MSAT), Environmental and Health Safety, Engineering and Property Services, Quality Assurance, Sterility Assurance, Network Strategy, Automation, and Operations to ensure alignment with technology evaluation and technical standards.
• Offer technical support for Global Business Development by leading technical assessments for L&A (license/acquisition)/M&A (merger/acquisition) business development opportunities.
• Assess network capabilities and strategic planning capacity across the platform.
• Proactively research and implement new technologies to drive business growth and efficiency.
• Stay on top of industry trends through benchmarking.
• Lead the business case development and engineering design through the concept phase/capital approval of capital project appropriations and process improvement projects.
• Regularly update senior management on project status, costs, and performance against targets.
• Ensure detailed documentation of all engineering activities.
• Provide technical support to both the internal and external (CMO) Biotherapeutic and Synthetic aseptic drug product network to solve sophisticated technical engineering and manufacturing problems.
• Cultivate a culture of technical excellence, partnership, and innovation to enable multi-functional learning and standard methodology sharing.

Requirements

• A minimum of a Bachelor’s degree in Engineering is required.
• A minimum of 10 years of process engineering and capital execution experience in a Biotherapeutic aseptic drug product manufacturing environment.
• Hands-on experience in the C&Q (commissioning and qualification) of Biotherapeutic aseptic drug product process equipment (compounding, filtration, filling, and automated visual inspection) is required.
• Ability to synthesize strategies, business needs, engineering elements, and technology inputs into data driven business solutions is required.
• Large capital project management experience in the range of $1 million to $20 million is required (preferred).
• Must be fluent in written and spoken German and English.
• Fluency in Dutch is a plus.

Benefits

• Inclusive work environment
• Reasonable accommodation for individuals with disabilities