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Senior automation engineer (biotech process automation)

Werthenstein
Festanstellung
Randstad
Inserat online seit: 5 September
Beschreibung

Jobdetails
For one of our clients, an international pharmaceutical company, we are seeking aSenior Automation Engineer (Biotech Process Automation).
General Information :
Start date : 01.10.2025
Duration : 12 months with the possibility of extension
Workplace : Schachen, Luzern
Home office : 100% onsite, some home office days are possible after approval
Workload : 100%
Working hours : Standard
Your Profile :
You are a seasoned professional withat least 5 years of experience in automation controls, specifically withDeltaV. You have a proven track record of working in acGMPor other highly regulated industry, such asBiologics,Medical Devices, orFood. You're not just an engineer; you're an expert incomputer validation (GAMP 5)and change control, with a strong understanding ofISA 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.
mehr anzeigen
For one of our clients, an international pharmaceutical company, we are seeking aSenior Automation Engineer (Biotech Process Automation).
General Information :
Start date : 01.10.2025
Duration : 12 months with the possibility of extension
Workplace : Schachen, Luzern
Home office : 100% onsite, some home office days are possible after approval
Workload : 100%
Working hours : Standard
Your Profile :
You are a seasoned professional withat least 5 years of experience in automation controls, specifically withDeltaV. You have a proven track record of working in acGMPor other highly regulated industry, such asBiologics,Medical Devices, orFood. You're not just an engineer; you're an expert incomputer validation (GAMP 5)and change control, with a strong understanding ofISA 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.
mehr anzeigen

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