Senior Automation Engineer

We are recruiting a Senior Automation Engineer for a 12-month temporary contract with an international pharmaceutical manufacturing company. The position involves supporting automation systems in a GMP-regulated production environment.

Responsibilities

• Inspire Diversity and Inclusion – building effective working relationships within a cross-functional team across different cultures and backgrounds.
• 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), SCADA (Ignition), 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.
• 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.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree in Life Science discipline or equivalent practical experience of at least 5 years of experience in automation controls.
• Thorough knowledge of computer validation/SDLC requirements and automation change control procedures. (e.g., GAMP 5)
• Effective oral / written communication skills in English (C1).
• Proven experience with DeltaV Batch design, implementation and test, including the ISA S95 and S88.
• Proven experience in DeltaV control strategy/Recipe implementation and administration for process equipment like Cytiva AktaRDY, AktaRDY XL, Sartorius Resolute BioSMB 80/350.
• 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 knowledge and/or working with an MES system (PAS-X, Syncade, Ignition MES) is advantageous.
• Commissioning and qualification, test protocol development and execution in Kneat eVal.

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