Descrizione dell’offerta di lavoro
- 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.
- 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.
Interested?
I look forward to your application.