Supports the design, implementation, and maintenance of OT systems at a regulated pharmaceutical manufacturing site. Maintains system reliability, cybersecurity, and GMP compliance across automation, laboratory, and manufacturing platforms, and supports validation, integration, troubleshooting, and disaster recovery. Responsibilities Manage PLC, HMI, SCADA, BAS/BMS, LIMS, and LMS systems, including architecture, configuration, and asset documentation. Maintain validated backups and conduct restoration testing for OT platforms. Lead OT scope for equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation. Integrate laboratory instruments with OT infrastructure and troubleshoot automated lab workflows. Troubleshoot automation faults and network issues with Engineering, QC, Maintenance, and IT teams. Implement cybersecurity controls, manage access and patching, support audits, and author SOPs and validation documents. Required Skills PLC systems HMI systems SCADA systems BAS/BMS systems LIMS and LMSOT system architecture Backup and disaster recovery FAT/SAT and commissioning Computer System Validation OT cybersecurity GMP compliance21 CFR Part 11 GAMP 5
11/14/2026
Full time
Supports the design, implementation, and maintenance of OT systems at a regulated pharmaceutical manufacturing site. Maintains system reliability, cybersecurity, and GMP compliance across automation, laboratory, and manufacturing platforms, and supports validation, integration, troubleshooting, and disaster recovery. Responsibilities Manage PLC, HMI, SCADA, BAS/BMS, LIMS, and LMS systems, including architecture, configuration, and asset documentation. Maintain validated backups and conduct restoration testing for OT platforms. Lead OT scope for equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation. Integrate laboratory instruments with OT infrastructure and troubleshoot automated lab workflows. Troubleshoot automation faults and network issues with Engineering, QC, Maintenance, and IT teams. Implement cybersecurity controls, manage access and patching, support audits, and author SOPs and validation documents. Required Skills PLC systems HMI systems SCADA systems BAS/BMS systems LIMS and LMSOT system architecture Backup and disaster recovery FAT/SAT and commissioning Computer System Validation OT cybersecurity GMP compliance21 CFR Part 11 GAMP 5
Lonza is seeking an IT Solution Architect to design and lead enterprise IT solutions that power cutting-edge biopharma development and manufacturing. In this role, you will translate complex business and scientific needs into secure, scalable architectures across applications, data, and infrastructure. You will partner with R&D, manufacturing, quality, and global IT teams to deliver compliant, GxP-ready solutions that support regulated operations. The position offers exposure to advanced technologies, cross-functional projects, and a culture focused on innovation, quality, and patient-centric outcomes. Responsibilities Design and architect IT solutions that support Lonza's biopharma development and manufacturing processes Translate business and scientific requirements into scalable, secure system architectures Lead end-to-end solution design across applications, data, and infrastructure domains Ensure solutions comply with Gx P and other regulatory and cybersecurity standards Collaborate with R&D, manufacturing, quality, and IT teams on global projects Evaluate and integrate cloud, data, and enterprise platforms to optimize operations Create architecture diagrams, technical specifications, and integration patterns Guide implementation teams and provide technical governance throughout projects Drive standardization, reuse, and lifecycle management of enterprise solutions Support continuous improvement and innovation in Lonza's digital ecosystem Required Skills Enterprise architecture design (applications, data, infrastructure) Cloud platforms (AWS, Azure, or GCP) Systems integration (APIs, ESB, microservices) Database and data architecture (SQL/No SQL, data modeling) Gx P and CSV compliance in regulated environments Cybersecurity and identity/access management Architecture frameworks (TOGAF or similar) Dev Ops and CI/CD concepts Documentation and modeling (UML, Archi Mate, Visio, or similar) Stakeholder management and technical leadership
11/14/2026
Full time
Lonza is seeking an IT Solution Architect to design and lead enterprise IT solutions that power cutting-edge biopharma development and manufacturing. In this role, you will translate complex business and scientific needs into secure, scalable architectures across applications, data, and infrastructure. You will partner with R&D, manufacturing, quality, and global IT teams to deliver compliant, GxP-ready solutions that support regulated operations. The position offers exposure to advanced technologies, cross-functional projects, and a culture focused on innovation, quality, and patient-centric outcomes. Responsibilities Design and architect IT solutions that support Lonza's biopharma development and manufacturing processes Translate business and scientific requirements into scalable, secure system architectures Lead end-to-end solution design across applications, data, and infrastructure domains Ensure solutions comply with Gx P and other regulatory and cybersecurity standards Collaborate with R&D, manufacturing, quality, and IT teams on global projects Evaluate and integrate cloud, data, and enterprise platforms to optimize operations Create architecture diagrams, technical specifications, and integration patterns Guide implementation teams and provide technical governance throughout projects Drive standardization, reuse, and lifecycle management of enterprise solutions Support continuous improvement and innovation in Lonza's digital ecosystem Required Skills Enterprise architecture design (applications, data, infrastructure) Cloud platforms (AWS, Azure, or GCP) Systems integration (APIs, ESB, microservices) Database and data architecture (SQL/No SQL, data modeling) Gx P and CSV compliance in regulated environments Cybersecurity and identity/access management Architecture frameworks (TOGAF or similar) Dev Ops and CI/CD concepts Documentation and modeling (UML, Archi Mate, Visio, or similar) Stakeholder management and technical leadership
Supports the design, implementation, and maintenance of OT systems at a regulated pharmaceutical manufacturing site. Maintains system reliability, cybersecurity, and GMP compliance across automation, laboratory, and manufacturing platforms, and supports validation, integration, troubleshooting, and disaster recovery. Responsibilities Manage PLC, HMI, SCADA, BAS/BMS, LIMS, and LMS systems, including architecture, configuration, and asset documentation. Maintain validated backups and conduct restoration testing for OT platforms. Lead OT scope for equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation. Integrate laboratory instruments with OT infrastructure and troubleshoot automated lab workflows. Troubleshoot automation faults and network issues with Engineering, QC, Maintenance, and IT teams. Implement cybersecurity controls, manage access and patching, support audits, and author SOPs and validation documents. Required Skills PLC systems HMI systems SCADA systems BAS/BMS systems LIMS and LMSOT system architecture Backup and disaster recovery FAT/SAT and commissioning Computer System Validation OT cybersecurity GMP compliance21 CFR Part 11 GAMP 5
11/14/2026
Full time
Supports the design, implementation, and maintenance of OT systems at a regulated pharmaceutical manufacturing site. Maintains system reliability, cybersecurity, and GMP compliance across automation, laboratory, and manufacturing platforms, and supports validation, integration, troubleshooting, and disaster recovery. Responsibilities Manage PLC, HMI, SCADA, BAS/BMS, LIMS, and LMS systems, including architecture, configuration, and asset documentation. Maintain validated backups and conduct restoration testing for OT platforms. Lead OT scope for equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation. Integrate laboratory instruments with OT infrastructure and troubleshoot automated lab workflows. Troubleshoot automation faults and network issues with Engineering, QC, Maintenance, and IT teams. Implement cybersecurity controls, manage access and patching, support audits, and author SOPs and validation documents. Required Skills PLC systems HMI systems SCADA systems BAS/BMS systems LIMS and LMSOT system architecture Backup and disaster recovery FAT/SAT and commissioning Computer System Validation OT cybersecurity GMP compliance21 CFR Part 11 GAMP 5
Lonza is seeking an Automation & MES Delivery Lead to drive design, implementation, and lifecycle management of manufacturing execution and automation systems in a regulated biopharmaceutical environment. You will lead end-to-end delivery of MES/automation solutions for drug substance and drug product facilities, translating manufacturing and quality requirements into robust digital workflows. Responsibilities include solution architecture, vendor and system integration oversight, project delivery, validation support, and continuous improvement. You will partner with operations, QA, IT, and global engineering, ensuring GxP compliance, data integrity, and high system reliability in support of safe, efficient, and scalable biopharma production. Responsibilities Lead end-to-end delivery of MES and automation solutions for biopharma manufacturing sites Translate manufacturing, quality, and regulatory requirements into system designs and workflows Define solution architecture and oversee integration with ERP, LIMS, and control systems Coordinate vendors, internal IT, engineering, and operations for successful project execution Support computer system validation, testing, and documentation in line with Gx P and data integrity Monitor and improve system performance, reliability, and user experience Drive standardization and continuous improvement of MES/automation templates and processes Ensure compliance with global and local regulations, including 21 CFR Part 11 Provide subject matter expertise and training to end users and project teams Contribute to digitalization roadmap and technology selection for manufacturing IT/OT Required Skills Manufacturing Execution Systems (MES) Automation systems (PLC/SCADA/DCS) System integration and interfaces (ERP/LIMS/Delta V/SAP) Gx P and FDA/EMA regulations Computer system validation (CSV)21 CFR Part 11 and data integrity Requirements gathering and process mapping Project and delivery management Biopharmaceutical manufacturing processes Change management and continuous improvement
11/14/2026
Full time
Lonza is seeking an Automation & MES Delivery Lead to drive design, implementation, and lifecycle management of manufacturing execution and automation systems in a regulated biopharmaceutical environment. You will lead end-to-end delivery of MES/automation solutions for drug substance and drug product facilities, translating manufacturing and quality requirements into robust digital workflows. Responsibilities include solution architecture, vendor and system integration oversight, project delivery, validation support, and continuous improvement. You will partner with operations, QA, IT, and global engineering, ensuring GxP compliance, data integrity, and high system reliability in support of safe, efficient, and scalable biopharma production. Responsibilities Lead end-to-end delivery of MES and automation solutions for biopharma manufacturing sites Translate manufacturing, quality, and regulatory requirements into system designs and workflows Define solution architecture and oversee integration with ERP, LIMS, and control systems Coordinate vendors, internal IT, engineering, and operations for successful project execution Support computer system validation, testing, and documentation in line with Gx P and data integrity Monitor and improve system performance, reliability, and user experience Drive standardization and continuous improvement of MES/automation templates and processes Ensure compliance with global and local regulations, including 21 CFR Part 11 Provide subject matter expertise and training to end users and project teams Contribute to digitalization roadmap and technology selection for manufacturing IT/OT Required Skills Manufacturing Execution Systems (MES) Automation systems (PLC/SCADA/DCS) System integration and interfaces (ERP/LIMS/Delta V/SAP) Gx P and FDA/EMA regulations Computer system validation (CSV)21 CFR Part 11 and data integrity Requirements gathering and process mapping Project and delivery management Biopharmaceutical manufacturing processes Change management and continuous improvement
Lonza is seeking an IT Solution Architect to design and implement scalable, secure IT solutions that support biopharma development and manufacturing. In this role, you will translate scientific and business needs into robust architectures, integrating lab, manufacturing, and enterprise systems in a GxP-regulated environment. You will collaborate with global, cross-functional teams, ensure compliance and data integrity, and drive standardization and innovation across Lonza's digital landscape. This position offers exposure to advanced technologies, international projects, and a mission-driven culture focused on patient outcomes. Responsibilities Design and implement IT solutions supporting Lonza's biopharma manufacturing and development processes Translate business and scientific requirements into scalable, secure IT architectures Integrate laboratory, manufacturing, and enterprise systems ensuring data integrity and compliance Collaborate with cross-functional teams across global sites to deliver end-to-end solutions Ensure architectures meet regulatory, Gx P, security, and quality standards Evaluate and select appropriate technologies, platforms, and integration patterns Create technical documentation, diagrams, and standards for implemented solutions Lead solution design reviews and provide technical guidance to project teams Support lifecycle management, upgrades, and optimization of IT systems Contribute to continuous improvement and innovation in Lonza's digital landscape Required Skills Solution architecture Enterprise integration (APIs, ESB, middleware) Cloud platforms (AWS, Azure, or GCP) Gx P and CSV compliance Biotech/pharma manufacturing or lab systems (LIMS, MES, ERP) Information security and data integrity Requirements analysis and stakeholder management System design and technical documentation Database and data modeling Project delivery in regulated environments
11/14/2026
Full time
Lonza is seeking an IT Solution Architect to design and implement scalable, secure IT solutions that support biopharma development and manufacturing. In this role, you will translate scientific and business needs into robust architectures, integrating lab, manufacturing, and enterprise systems in a GxP-regulated environment. You will collaborate with global, cross-functional teams, ensure compliance and data integrity, and drive standardization and innovation across Lonza's digital landscape. This position offers exposure to advanced technologies, international projects, and a mission-driven culture focused on patient outcomes. Responsibilities Design and implement IT solutions supporting Lonza's biopharma manufacturing and development processes Translate business and scientific requirements into scalable, secure IT architectures Integrate laboratory, manufacturing, and enterprise systems ensuring data integrity and compliance Collaborate with cross-functional teams across global sites to deliver end-to-end solutions Ensure architectures meet regulatory, Gx P, security, and quality standards Evaluate and select appropriate technologies, platforms, and integration patterns Create technical documentation, diagrams, and standards for implemented solutions Lead solution design reviews and provide technical guidance to project teams Support lifecycle management, upgrades, and optimization of IT systems Contribute to continuous improvement and innovation in Lonza's digital landscape Required Skills Solution architecture Enterprise integration (APIs, ESB, middleware) Cloud platforms (AWS, Azure, or GCP) Gx P and CSV compliance Biotech/pharma manufacturing or lab systems (LIMS, MES, ERP) Information security and data integrity Requirements analysis and stakeholder management System design and technical documentation Database and data modeling Project delivery in regulated environments
Lonza is seeking an Automation & MES Delivery Lead to drive design, implementation, and lifecycle management of manufacturing execution and automation systems in a regulated biopharmaceutical environment. You will lead end-to-end delivery of MES/automation solutions for drug substance and drug product facilities, translating manufacturing and quality requirements into robust digital workflows. Responsibilities include solution architecture, vendor and system integration oversight, project delivery, validation support, and continuous improvement. You will partner with operations, QA, IT, and global engineering, ensuring GxP compliance, data integrity, and high system reliability in support of safe, efficient, and scalable biopharma production. Responsibilities Lead end-to-end delivery of MES and automation solutions for biopharma manufacturing sites Translate manufacturing, quality, and regulatory requirements into system designs and workflows Define solution architecture and oversee integration with ERP, LIMS, and control systems Coordinate vendors, internal IT, engineering, and operations for successful project execution Support computer system validation, testing, and documentation in line with Gx P and data integrity Monitor and improve system performance, reliability, and user experience Drive standardization and continuous improvement of MES/automation templates and processes Ensure compliance with global and local regulations, including 21 CFR Part 11 Provide subject matter expertise and training to end users and project teams Contribute to digitalization roadmap and technology selection for manufacturing IT/OT Required Skills Manufacturing Execution Systems (MES) Automation systems (PLC/SCADA/DCS) System integration and interfaces (ERP/LIMS/Delta V/SAP) Gx P and FDA/EMA regulations Computer system validation (CSV)21 CFR Part 11 and data integrity Requirements gathering and process mapping Project and delivery management Biopharmaceutical manufacturing processes Change management and continuous improvement
11/14/2026
Full time
Lonza is seeking an Automation & MES Delivery Lead to drive design, implementation, and lifecycle management of manufacturing execution and automation systems in a regulated biopharmaceutical environment. You will lead end-to-end delivery of MES/automation solutions for drug substance and drug product facilities, translating manufacturing and quality requirements into robust digital workflows. Responsibilities include solution architecture, vendor and system integration oversight, project delivery, validation support, and continuous improvement. You will partner with operations, QA, IT, and global engineering, ensuring GxP compliance, data integrity, and high system reliability in support of safe, efficient, and scalable biopharma production. Responsibilities Lead end-to-end delivery of MES and automation solutions for biopharma manufacturing sites Translate manufacturing, quality, and regulatory requirements into system designs and workflows Define solution architecture and oversee integration with ERP, LIMS, and control systems Coordinate vendors, internal IT, engineering, and operations for successful project execution Support computer system validation, testing, and documentation in line with Gx P and data integrity Monitor and improve system performance, reliability, and user experience Drive standardization and continuous improvement of MES/automation templates and processes Ensure compliance with global and local regulations, including 21 CFR Part 11 Provide subject matter expertise and training to end users and project teams Contribute to digitalization roadmap and technology selection for manufacturing IT/OT Required Skills Manufacturing Execution Systems (MES) Automation systems (PLC/SCADA/DCS) System integration and interfaces (ERP/LIMS/Delta V/SAP) Gx P and FDA/EMA regulations Computer system validation (CSV)21 CFR Part 11 and data integrity Requirements gathering and process mapping Project and delivery management Biopharmaceutical manufacturing processes Change management and continuous improvement
Lead the Vacaville site's SAP S/4HANA transformation and oversee its SAP ERP environment. Partner with site and global leaders to ensure compliant, validated systems, business readiness, successful deployment, and sustained adoption across manufacturing operations. Responsibilities Lead site deployment of SAP S/4 HANA, coordinating planning, testing, data readiness, training, cutover, go-live, and hypercare. Own business process governance for the site's SAP ERP environment and maintain validated, compliant systems and processes. Collaborate with process owners and stakeholders to deliver ERP enhancements that meet business requirements and service levels. Partner with site and global leadership on reporting, risk assessments, decision support, and ERP strategy. Drive business readiness, user competency, process standardization, and adoption of global SAP standards. Manage governance, project plans, RAID tracking, dashboards, steering committee materials, and deployment milestones. Required Skills SAP S/4 HANA deployment SAP ERP administration SAP MMSAP PPSAP PMSAP WMSAP FISAP QMERP validation and compliance ERP project and change management
11/04/2026
Full time
Lead the Vacaville site's SAP S/4HANA transformation and oversee its SAP ERP environment. Partner with site and global leaders to ensure compliant, validated systems, business readiness, successful deployment, and sustained adoption across manufacturing operations. Responsibilities Lead site deployment of SAP S/4 HANA, coordinating planning, testing, data readiness, training, cutover, go-live, and hypercare. Own business process governance for the site's SAP ERP environment and maintain validated, compliant systems and processes. Collaborate with process owners and stakeholders to deliver ERP enhancements that meet business requirements and service levels. Partner with site and global leadership on reporting, risk assessments, decision support, and ERP strategy. Drive business readiness, user competency, process standardization, and adoption of global SAP standards. Manage governance, project plans, RAID tracking, dashboards, steering committee materials, and deployment milestones. Required Skills SAP S/4 HANA deployment SAP ERP administration SAP MMSAP PPSAP PMSAP WMSAP FISAP QMERP validation and compliance ERP project and change management