Sr Mfg Systems Engineer - MES
Amgen
Sr Mfg Systems Engineer - MES
Job Description
Sr Manufacturing Systems Engineer – MES (Amgen India, AIN)
What you will do
- Lead lifecycle upgrades, migrations, and enhancements of MES systems across Amgen manufacturing sites.
- Serve as a technical SME for MES, supporting Core and site MES infrastructure and ensuring high availability, performance, and compliance.
- Collaborate with global manufacturing, automation, and IT teams to design, implement, and validate MES solutions for data acquisition, integration, and reporting.
- Develop and maintain documentation, standards, and best practices for MES system architecture, security, and data governance.
- Troubleshoot and resolve complex MES system issues, providing advanced support to end users at the sites.
- Drive continuous improvement initiatives, leveraging MES data for process optimization, predictive analytics, and digital manufacturing projects.
- Participate in global MES COE activities, knowledge sharing, and training for site teams.
- Ensure compliance with regulatory requirements and Amgen’s quality standards in all MES system activities.
- Support audits, validation, and change management processes related to MES systems.
- Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgen’s business objectives and digital transformation initiatives.
- Help to define and enforce best-in-class standards, methodologies, and governance for MES architecture, integration, cybersecurity, data integrity, and regulatory compliance (e.g., GxP, CFR Part 11).
- Drive harmonization of MES business processes and technical implementations across global sites, leveraging ISA-95 and other relevant manufacturing standards.
- Guide the evaluation and adoption of emerging technologies (e.g., IIoT, data lakes, AI/ML, containerization) to enhance MES capabilities and support advanced manufacturing use cases.
- Implement and support the solution architecture, design, deployment, and lifecycle management of NextGen MES platforms—with a focus on PAS|X, SAP integration, automation interfaces, and cloud adoption—across all manufacturing sites.
- Foster a culture of innovation, knowledge sharing, and continuous improvement within the COE and the wider global MES community.
- Ensure comprehensive documentation, knowledge management, and training programs to support global system adoption and sustainability.
- Champion change management strategies to enable successful MES transformation and adoption at all levels of the organization.
What we expect of you
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (or Master’s degree with relevant experience).
- 8+ years of experience in manufacturing systems engineering, with 3+ years focused on MES or similar industrial data platforms.
- Hands-on experience with MES System lifecycle management, upgrades, and enterprise deployments.
- Hands-on experience with MES solution architecture, deployment, and lifecycle management in a GMP-regulated pharmaceutical, biotechnology, or manufacturing environment.
- Extensive experience with PAS|X MES (including v3.3 or higher), SAP integration, and Level 2/3 automation systems.
- Proven track record leading global, multi-site MES transformation programs, including direct management and mentorship of technical teams.
- Deep understanding of GxP regulations, CSV/CSA, and SDLC best practices.
- Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes).
- Excellent communication, relationship-building, and stakeholder engagement skills.
Must-Have Skills
- Expertise with Korber PAS|X MES, including eBR, Equipment Management, Weigh & Dispense, etc.
- Familiarity with international MES standards (ISA-95, GAMP, etc.).
- Experience representing MES programs with regulatory agencies and external partners.
- Experience with SAP MES integration and automation platforms (Rockwell, DeltaV, OPC UA, Pi).
- Proficiency with modern data platforms (PostgreSQL, data lakes, data fabric) and containerized application deployment (e.g., Kubernetes).
- Professional certifications (MES, SAP, Project Management/PMP, or equivalent).
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expertise with Korber PAS|X MES, including eBR, Equipment Management, Weigh & Dispense, etc.intermediate
- Familiarity with international MES standards (ISA-95, GAMP, etc.).intermediate
- Experience representing MES programs with regulatory agencies and external partners.intermediate
- Experience with SAP MES integration and automation platforms (Rockwell, DeltaV, OPC UA, Pi).intermediate
- Proficiency with modern data platforms (PostgreSQL, data lakes, data fabric) and containerized application deployment (e.g., Kubernetes).intermediate
- Professional certifications (MES, SAP, Project Management/PMP, or equivalent).intermediate
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (or Master’s degree with relevant experience). (experience)
- 8+ years of experience in manufacturing systems engineering, with 3+ years focused on MES or similar industrial data platforms. (experience)
- Hands-on experience with MES System lifecycle management, upgrades, and enterprise deployments. (experience)
- Hands-on experience with MES solution architecture, deployment, and lifecycle management in a GMP-regulated pharmaceutical, biotechnology, or manufacturing environment. (experience)
- Extensive experience with PAS|X MES (including v3.3 or higher), SAP integration, and Level 2/3 automation systems. (experience)
- Proven track record leading global, multi-site MES transformation programs, including direct management and mentorship of technical teams. (experience)
- Deep understanding of GxP regulations, CSV/CSA, and SDLC best practices. (experience)
- Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes). (experience)
- Excellent communication, relationship-building, and stakeholder engagement skills. (experience)
Responsibilities
- Lead lifecycle upgrades, migrations, and enhancements of MES systems across Amgen manufacturing sites.
- Serve as a technical SME for MES, supporting Core and site MES infrastructure and ensuring high availability, performance, and compliance.
- Collaborate with global manufacturing, automation, and IT teams to design, implement, and validate MES solutions for data acquisition, integration, and reporting.
- Develop and maintain documentation, standards, and best practices for MES system architecture, security, and data governance.
- Troubleshoot and resolve complex MES system issues, providing advanced support to end users at the sites.
- Drive continuous improvement initiatives, leveraging MES data for process optimization, predictive analytics, and digital manufacturing projects.
- Participate in global MES COE activities, knowledge sharing, and training for site teams.
- Ensure compliance with regulatory requirements and Amgen’s quality standards in all MES system activities.
- Support audits, validation, and change management processes related to MES systems.
- Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgen’s business objectives and digital transformation initiatives.
- Help to define and enforce best-in-class standards, methodologies, and governance for MES architecture, integration, cybersecurity, data integrity, and regulatory compliance (e.g., GxP, CFR Part 11).
- Drive harmonization of MES business processes and technical implementations across global sites, leveraging ISA-95 and other relevant manufacturing standards.
- Guide the evaluation and adoption of emerging technologies (e.g., IIoT, data lakes, AI/ML, containerization) to enhance MES capabilities and support advanced manufacturing use cases.
- Implement and support the solution architecture, design, deployment, and lifecycle management of NextGen MES platforms—with a focus on PAS|X, SAP integration, automation interfaces, and cloud adoption—across all manufacturing sites.
- Foster a culture of innovation, knowledge sharing, and continuous improvement within the COE and the wider global MES community.
- Ensure comprehensive documentation, knowledge management, and training programs to support global system adoption and sustainability.
- Champion change management strategies to enable successful MES transformation and adoption at all levels of the organization.
Tags & Categories
Sr Mfg Systems Engineer - MES
Amgen
Sr Mfg Systems Engineer - MES
Job Description
Sr Manufacturing Systems Engineer – MES (Amgen India, AIN)
What you will do
- Lead lifecycle upgrades, migrations, and enhancements of MES systems across Amgen manufacturing sites.
- Serve as a technical SME for MES, supporting Core and site MES infrastructure and ensuring high availability, performance, and compliance.
- Collaborate with global manufacturing, automation, and IT teams to design, implement, and validate MES solutions for data acquisition, integration, and reporting.
- Develop and maintain documentation, standards, and best practices for MES system architecture, security, and data governance.
- Troubleshoot and resolve complex MES system issues, providing advanced support to end users at the sites.
- Drive continuous improvement initiatives, leveraging MES data for process optimization, predictive analytics, and digital manufacturing projects.
- Participate in global MES COE activities, knowledge sharing, and training for site teams.
- Ensure compliance with regulatory requirements and Amgen’s quality standards in all MES system activities.
- Support audits, validation, and change management processes related to MES systems.
- Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgen’s business objectives and digital transformation initiatives.
- Help to define and enforce best-in-class standards, methodologies, and governance for MES architecture, integration, cybersecurity, data integrity, and regulatory compliance (e.g., GxP, CFR Part 11).
- Drive harmonization of MES business processes and technical implementations across global sites, leveraging ISA-95 and other relevant manufacturing standards.
- Guide the evaluation and adoption of emerging technologies (e.g., IIoT, data lakes, AI/ML, containerization) to enhance MES capabilities and support advanced manufacturing use cases.
- Implement and support the solution architecture, design, deployment, and lifecycle management of NextGen MES platforms—with a focus on PAS|X, SAP integration, automation interfaces, and cloud adoption—across all manufacturing sites.
- Foster a culture of innovation, knowledge sharing, and continuous improvement within the COE and the wider global MES community.
- Ensure comprehensive documentation, knowledge management, and training programs to support global system adoption and sustainability.
- Champion change management strategies to enable successful MES transformation and adoption at all levels of the organization.
What we expect of you
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (or Master’s degree with relevant experience).
- 8+ years of experience in manufacturing systems engineering, with 3+ years focused on MES or similar industrial data platforms.
- Hands-on experience with MES System lifecycle management, upgrades, and enterprise deployments.
- Hands-on experience with MES solution architecture, deployment, and lifecycle management in a GMP-regulated pharmaceutical, biotechnology, or manufacturing environment.
- Extensive experience with PAS|X MES (including v3.3 or higher), SAP integration, and Level 2/3 automation systems.
- Proven track record leading global, multi-site MES transformation programs, including direct management and mentorship of technical teams.
- Deep understanding of GxP regulations, CSV/CSA, and SDLC best practices.
- Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes).
- Excellent communication, relationship-building, and stakeholder engagement skills.
Must-Have Skills
- Expertise with Korber PAS|X MES, including eBR, Equipment Management, Weigh & Dispense, etc.
- Familiarity with international MES standards (ISA-95, GAMP, etc.).
- Experience representing MES programs with regulatory agencies and external partners.
- Experience with SAP MES integration and automation platforms (Rockwell, DeltaV, OPC UA, Pi).
- Proficiency with modern data platforms (PostgreSQL, data lakes, data fabric) and containerized application deployment (e.g., Kubernetes).
- Professional certifications (MES, SAP, Project Management/PMP, or equivalent).
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expertise with Korber PAS|X MES, including eBR, Equipment Management, Weigh & Dispense, etc.intermediate
- Familiarity with international MES standards (ISA-95, GAMP, etc.).intermediate
- Experience representing MES programs with regulatory agencies and external partners.intermediate
- Experience with SAP MES integration and automation platforms (Rockwell, DeltaV, OPC UA, Pi).intermediate
- Proficiency with modern data platforms (PostgreSQL, data lakes, data fabric) and containerized application deployment (e.g., Kubernetes).intermediate
- Professional certifications (MES, SAP, Project Management/PMP, or equivalent).intermediate
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (or Master’s degree with relevant experience). (experience)
- 8+ years of experience in manufacturing systems engineering, with 3+ years focused on MES or similar industrial data platforms. (experience)
- Hands-on experience with MES System lifecycle management, upgrades, and enterprise deployments. (experience)
- Hands-on experience with MES solution architecture, deployment, and lifecycle management in a GMP-regulated pharmaceutical, biotechnology, or manufacturing environment. (experience)
- Extensive experience with PAS|X MES (including v3.3 or higher), SAP integration, and Level 2/3 automation systems. (experience)
- Proven track record leading global, multi-site MES transformation programs, including direct management and mentorship of technical teams. (experience)
- Deep understanding of GxP regulations, CSV/CSA, and SDLC best practices. (experience)
- Demonstrated expertise with IT/OT cybersecurity, data integrity, cloud-based architectures, and emerging digital manufacturing platforms (e.g., IIoT, AI/ML, data lakes). (experience)
- Excellent communication, relationship-building, and stakeholder engagement skills. (experience)
Responsibilities
- Lead lifecycle upgrades, migrations, and enhancements of MES systems across Amgen manufacturing sites.
- Serve as a technical SME for MES, supporting Core and site MES infrastructure and ensuring high availability, performance, and compliance.
- Collaborate with global manufacturing, automation, and IT teams to design, implement, and validate MES solutions for data acquisition, integration, and reporting.
- Develop and maintain documentation, standards, and best practices for MES system architecture, security, and data governance.
- Troubleshoot and resolve complex MES system issues, providing advanced support to end users at the sites.
- Drive continuous improvement initiatives, leveraging MES data for process optimization, predictive analytics, and digital manufacturing projects.
- Participate in global MES COE activities, knowledge sharing, and training for site teams.
- Ensure compliance with regulatory requirements and Amgen’s quality standards in all MES system activities.
- Support audits, validation, and change management processes related to MES systems.
- Oversee and execute the global MES roadmap and lifecycle strategy, ensuring alignment with Amgen’s business objectives and digital transformation initiatives.
- Help to define and enforce best-in-class standards, methodologies, and governance for MES architecture, integration, cybersecurity, data integrity, and regulatory compliance (e.g., GxP, CFR Part 11).
- Drive harmonization of MES business processes and technical implementations across global sites, leveraging ISA-95 and other relevant manufacturing standards.
- Guide the evaluation and adoption of emerging technologies (e.g., IIoT, data lakes, AI/ML, containerization) to enhance MES capabilities and support advanced manufacturing use cases.
- Implement and support the solution architecture, design, deployment, and lifecycle management of NextGen MES platforms—with a focus on PAS|X, SAP integration, automation interfaces, and cloud adoption—across all manufacturing sites.
- Foster a culture of innovation, knowledge sharing, and continuous improvement within the COE and the wider global MES community.
- Ensure comprehensive documentation, knowledge management, and training programs to support global system adoption and sustainability.
- Champion change management strategies to enable successful MES transformation and adoption at all levels of the organization.
Tags & Categories