Senior Automation Engineer (Biotech Process Automation)

You are a seasoned professional with at least 5 years of experience in automation controls, specifically with DeltaV. You have a proven track record of working in a cGMP or other highly regulated industry, such as Biologics, Medical Devices, or Food. You're not just an engineer; you're an expert in computer validation (GAMP 5) and change control, with a strong understanding of ISA S95 and S88.

Tasks & Responsibilities:

• Serve as a Subject Matter Expert for the implementation of control strategies for new equipment to enhance manufacturing processes in a Good Manufacturing Practice (GMP) environment
• Implement innovative technologies, software, control strategies, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processes
• Provide key automation support for various manufacturing systems such as DCS (DeltaV), MES(PAS-X), PLC, SCADA, and OEM systems
• Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation
• Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP
• Transfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supply
• Lead automation related investigations into deviations and implement corrective actions.
• Inspire Diversity and Inclusion – building effective working relationships within a cross functional team across different cultures and backgrounds
• Working with external companies, organizing spare parts and service visits
• Supporting the qualification of new systems. Write, review, and/or execute test documents.
• Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problems
• Participate and actively support Digital Transformation initiatives involving system integrations, data connectivity, data analysis/modelling, validation methods and value-based optimization of manufacturing via process control system
• Limited off shift work may be required to meet project, operations, and qualification needs

Requirements:

• Bachelor’s degree in a Life Science discipline or equivalent practical experience of at least 5 years of experience in automation controls (DeltaV DCS)
• Thorough knowledge of computer validation/SDLC requirements and automation change control procedures (e.g., GAMP 5)
• Effective oral / written communication skills in English (C1), German is nice to have
• Proven experience with DeltaV DCS, DeltaV Batch, including the ISA S95 and S88
• At least 3 years of experience in Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industries
• Proven experience with development and implementation of industrial controls such as DCS (Delta V), MES (PAS-X), Historian (PI)
• I/O Networking experience (i.e. Ethernet/IP, OPC, Profinet, and ModBus protocols) is advantageous
• Basic networking experience
• Commissioning and qualification, test protocol development and execution.

Sound interesting? Apply Now - we are looking forward to receiving your application.