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Amgen Inc
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Principal Mfg Systems Engineer

Principal Mfg Systems Engineer

Amgen Inc

12 - 17 years

12 - 16 Lacs

hyderabad

Posted:4 weeks ago| Platform:

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Skills Required

data validation csv software development life cycle technical documentation gxp kubernetes biotechnology sap automation systems data integrity gmp sap s hana solution design regulations manufacturing mes information systems sdlc

Work Mode

Work from Office

Job Type

Full Time

Job Description

What you will do

In this vital role you will responsible for architecting, integrating, and deploying advanced MES solutions, with a focus on PAS|X MES platforms, seamless SAP ERP and Level 2 automation system interfaces, and leveraging the latest in cloud and digital technologies.

As a member of Amgens Digital, Technology & Innovation organization, you will collaborate with global teams of engineers, automation specialists, IT professionals, and operations leadership to deliver robust, scalable, and compliant MES solutions. Your leadership will help drive the transformation of Amgens manufacturing network, ensuring operational excellence, compliance, and agility for future growth.

Roles & Responsibilities

Lead end-to-end design, configuration, and implementation of Amgens NextGen MES, with a focus on PAS|X platform technical deployments.
Drive system modernization and digital transformation by leveraging state-of-the-art technologies and integrating MES with enterprise systems (SAP, Level 2 automation, data historians, and cloud platforms).
Serve as the technical authority and SME for PAS|X MES implementations, including requirements gathering, solution architecture, interface design, and system validation.
Develop and maintain strong partnerships with Operations, Quality, Automation, IT, and global business collaborators to ensure MES solutions align with strategic goals and user needs.
Oversee and manage multi-functional project teams and external partners through all project phasesdesign, build, test, deployment, and hypercareensuring delivery commitments are met.
Champion and implement best-in-class standards for system integration, data integrity, cybersecurity, and regulatory compliance (e.g., GxP, CFR Part 11).
Define and drive technology strategies for MES system enhancements, scalability, and cloud readiness, supporting Amgens digital transformation journey.
Develop and deliver clear documentation, including functional/technical specifications, validation protocols, and training materials.
Mentor and provide technical guidance to junior engineers and team members, fostering a culture of innovation, collaboration, and continuous improvement.
Support change management strategies to ensure successful system adoption across global manufacturing sites.
Serve as the partner concern point for critical MES technical challenges, incident response, and root cause analysis.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years Engineering, Computer Science, Information Systems, or a related field.
Minimum 5+ years hands-on experience implementing and supporting PAS|X MES in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
Extensive technical expertise in MES solution design, configuration, and integration with SAP (PP, QM, MM modules), and Level 2 automation systems (e.g., PLCs, SCADA, DCS, OPC).
Proven track record of leading complex, multi-site MES projects from concept through validation and go-live.
In-depth knowledge of software development life cycle (SDLC), GxP regulations, and CSV/validation best practices.
Experience with IT/OT cybersecurity, data integrity, and cloud-based MES architectures is highly desirable.
Strong skills in technical documentation, collaborator engagement, and multi-functional communication.

Preferred Qualifications

Expertise with PAS|X MES advanced modules (eBR, Equipment Management, Weigh & Dispense, Master Batch Record configuration).
Experience integrating MES with SAP S/4HANA and/or advanced automation/data platforms.
Familiarity with ISA-95 standards, data lakes, and supporting digital manufacturing initiatives (e.g., IIoT, AI/ML for manufacturing data).
Experience working across global, matrixed teams and/or as a technical leader for external vendors/partners.
Professional certifications in MES, SAP, or project management are a plus.
Experience with containers / Kubernetes

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Amgen Inc

Biotechnology

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Principal Mfg Systems Engineer