Senior Automation Engineer
Join an international pharmaceutical manufacturing company on a 12-month temporary contract to support automation systems within a GMP-regulated production environment. This role requires a Subject Matter Expert to drive innovation, streamline processes, and ensure compliance in a dynamic cross-functional team.
Key Responsibilities
- Inspire diversity and inclusion by 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 tasks.
- Provide key automation support for various manufacturing systems, including DCS (DeltaV), MES (PAS-X), SCADA (Ignition), and OEM systems.
- Support and/or direct Continuous Improvement projects, including automation review of equipment specifications, P&IDs, and System Life Cycle documentation.
- Troubleshoot challenging equipment and automation issues to improve manufacturing performance, support new product changes, and maintain automation systems in compliance with cGMP.
- Transfer process technologies from early-stage pipeline facilities to GMP Operational Status and support line of sight to commercial supply.
- Lead automation-related investigations into deviations and implement corrective actions.
- Collaborate with external companies to organize spare parts and service visits.
- Support the qualification of new systems by writing, reviewing, and/or executing test documents.
- Collaborate within Operations, Quality, Validation, and Technical organizations to resolve complex problems.
- Participate in 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 systems.
- Perform limited off-shift work as required to meet project, operations, and qualification needs.
Required Skills and Experience
- Bachelor’s degree in a Life Science discipline or equivalent practical experience of at least 5 years in automation controls.
- Thorough knowledge of computer validation/SDLC requirements and automation change control procedures (e.g., GAMP 5).
- Effective oral and written communication skills in English (C1).
- Proven experience with DeltaV Batch design, implementation, and testing, including ISA S95 and S88 standards.
- Proven experience in DeltaV control strategy, recipe implementation, and administration for process equipment such as Cytiva AktaRDY, AktaRDY XL, and Sartorius Resolute BioSMB 80/350.
- At least 3 years of experience in an Automation or Engineering function within the Biologics, Food, Medical Devices, or pharmaceutical industries.
- Proven experience with the development and implementation of industrial controls such as DCS (DeltaV), MES (PAS-X), and Historian (PI).
- I/O Networking experience with protocols such as Ethernet/IP, OPC, Profinet, and ModBus is advantageous.
- Basic knowledge and/or working experience with MES systems (PAS-X, Syncade, Ignition MES) is advantageous.
- Experience with commissioning, qualification, test protocol development, and execution in Kneat eVal.