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Senior automation engineer (biotech process automation)

Schachen
Randstad
Inserat online seit: 7 September
Beschreibung

JobdetailsFor one of our clients, an international pharmaceutical company, we are seeking aSenior Automation Engineer (Biotech Process Automation).General Information :Start date : 01.10.2025Duration : 12 months with the possibility of extensionWorkplace : Schachen, LuzernHome office : 100% onsite, some home office days are possible after approvalWorkload : 100%Working hours : StandardYour 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) environmentImplement innovative technologies, software, control strategies, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processesProvide key automation support for various manufacturing systems such as DCS (DeltaV), MES(PAS-X), PLC, SCADA, and OEM systemsSupport and / or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentationResponsible 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 cGMPTransfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supplyLead 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 backgroundsWorking with external companies, organizing spare parts and service visitsSupporting the qualification of new systems. Write, review, and / or execute test documents.Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problemsParticipate 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 systemLimited off shift work may be required to meet project, operations, and qualification needsRequirements :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 haveProven experience with DeltaV DCS, DeltaV Batch, including the ISA S95 and S88At least 3 years of experience in Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industriesProven 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 advantageousBasic networking experienceCommissioning and qualification, test protocol development and execution.Sound interesting?Apply Now- we are looking forward to receiving your application.mehr anzeigenFor one of our clients, an international pharmaceutical company, we are seeking aSenior Automation Engineer (Biotech Process Automation).General Information :Start date : 01.10.2025Duration : 12 months with the possibility of extensionWorkplace : Schachen, LuzernHome office : 100% onsite, some home office days are possible after approvalWorkload : 100%Working hours : StandardYour 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) environmentImplement innovative technologies, software, control strategies, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processesProvide key automation support for various manufacturing systems such as DCS (DeltaV), MES(PAS-X), PLC, SCADA, and OEM systemsSupport and / or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentationResponsible 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 cGMPTransfer of Process Technologies from early-stage pipeline facilities and drive to GMP Operational Status, and support line of sight to commercial supplyLead 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 backgroundsWorking with external companies, organizing spare parts and service visitsSupporting the qualification of new systems. Write, review, and / or execute test documents.Collaborates within the Operations, Quality, Validation and Technical organizations to resolve complex problemsParticipate 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 systemLimited off shift work may be required to meet project, operations, and qualification needsRequirements :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 haveProven experience with DeltaV DCS, DeltaV Batch, including the ISA S95 and S88At least 3 years of experience in Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industriesProven 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 advantageousBasic networking experienceCommissioning 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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