Senior Berater

Astek US Inc. is part of the global Astek Group
, operating in 25 countries and supported by over 10,000 highly skilled professionals in IT and engineering. In the US, we specialize in IT consulting and engineering services for a variety of industry sectors.

Since 1988, our teams have been successfully driving our clients’ development strategies. Guided by shared values, we’ve built strong, trusted relationships by placing their needs at the core of everything we do.

• Analyze processes and manage business requirements for biotech production operations such as compounding, filling, and packaging, as well as provide consulting on best practices for designing production workflows.
• Design, enhance, and maintain production workflows in the Siemens Opcenter Execution Pharma MES system, ensuring compliance with regulatory requirements such as GMP and 21 CFR Part 11.
• Test and validate interface configurations, e.g., connecting the MES to other systems like ERP and SCADA, and validate recipe logic in simulated production environments.
• Prepare work instructions, validation documentation, and manufacturing records, and perform quality checks.
• Actively collaborate within the global project team and MES community to drive continuous improvement and standardization.

• Completed degree in a scientific or technical field or equivalent qualification.
• Experience in modeling Master Batch Records using Siemens Opcenter Execution Pharma.
• Solid knowledge of GxP regulations and pharmaceutical manufacturing processes.