Senior Compliance Engineer – Process Engineering

About the role

The Senior Compliance Engineer, Process Engineering, will lead engineering and qualification activities for process equipment, utilities, facilities and computerized systems in the Fill & Finish pilot plant. You will support validation, troubleshoot technical issues and drive continuous improvement in an aseptic environment.

Key responsibilities

• Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
• Lead troubleshooting, corrective actions and documentation for technical issues and non‑conformances, working with production teams, equipment suppliers and Quality Assurance.
• Manage technical changes and optimisation initiatives through the change‑control process and oversee the technical work‑order system.
• Deliver training and instructions to operators and staff at system and process level.
• Support evaluation, qualification and implementation of new technology platforms/processes in an aseptic environment.

Required profile

• 4–6 years of experience in pharmaceutical, food or chemical industry with hands‑on GMP compliance support.
• Proven experience specifying and designing process equipment and systems for aseptic environments.
• Strong troubleshooting skills, root‑cause analysis and ability to implement corrective actions.
• Fluent in German and English (written and spoken).

Required skills

• Process equipment design for aseptic environments
• HVAC systems knowledge
• SAP Product Lifecycle Management
• Technical writing and documentation
• Vendor selection and management
• Process control and process engineering