System Integration Manager

Roche

Kaiseraugst

On-site

CHF 120,000 - 160,000

Full time

5 days ago
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Job summary

Roche is seeking a System Integration Manager to ensure End-to-End stability across ASPIRE (ERP), MES, and eWM within the Steriles Manufacturing Unit. You will design robust testing, coordinate root-cause analyses, and serve as the Deviation Owner for interface-related quality incidents in a regulated GMP environment.

Responsibilities include governing data flows, leading CAPAs, and partnering with ERP, MES, and eWM teams to implement regression testing and change control.

Qualifications

  • Bachelor’s or Master’s degree in a technical field is required.
  • Experience in regulated pharma manufacturing and GMP/GAMP5 guidelines preferred.
  • Strong understanding of system interfaces and data flows across ERP, MES, and eWM.

Responsibilities

  • Act as the primary technical authority for interfaces and data flow between ERP, MES and eWM to prevent downtime.
  • Serve as Deviation Owner for interface-related quality incidents and lead rapid RCAs.
  • Develop and oversee CAPAs to reduce interface deviations.
  • Design and govern end-to-end regression testing across the integrated landscape.
  • Review system changes from an end-to-end perspective before production deployment.
  • Provide cross-system operational support and act as a knowledge center for the Steriles MU.

Skills

GMP compliance
Cross-functional collaboration
Crisis management
Regulatory terminology (FDA/EMA)

Education

Bachelor’s or Master’s degree in Computer Science or Engineering

Tools

ASPIRE (SAP S/4HANA)
MES (Syncade, Werum PAS-X)
eWM architectures

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As part of the manufacturing system landscape supporting the Steriles Manufacturing Unit, our teams collaborate across ERP, MES, and eWM environments to ensure continuous operational excellence. As we transition from hypercare into standard operations, this integrated technical group enables flawless manufacturing, maintains regulatory compliance, protects production output, and secures the critical delivery of PTM KAU DP.

The System Integration Manager is a critical role responsible for the End-to-End (E2E) stability, integration, and continuous operation of our core manufacturing systems (including ERP, MES, and eWM). Acting as a bridge between specialized support teams, you will design robust testing regimes, drive complex cross-system root cause analyses at system interfaces, and serve as the dedicated Deviation Owner for interface-related quality incidents to support the Steriles Manufacturing Unit.

The Opportunity
  • Serve as the primary technical authority for interfaces, master data, and data flow between ASPIRE (ERP), MES, and eWM, monitoring interactions to prevent downtime and bridging technical gaps across teams for a unified E2E architecture.
  • Act as the dedicated Deviation Owner for system- and interface-related quality incidents in a regulated GMP environment, leading rapid cross-functional Root Cause Analyses (RCAs) to resolve structural defects.
  • Develop, implement, and oversee Corrective and Preventive Actions (CAPAs) to systematically reduce the volume of interface-related deviations.
  • Partner with ERP, MES, and eWM teams to design, implement, and govern a comprehensive E2E regression testing regime across the integrated system landscape.
  • Manage testing and stabilization for asynchronous update cycles (e.g., quarterly ASPIRE updates, annual MES updates, and eWM releases) to guarantee localized changes do not disrupt inter-system workflows.
  • Review and approve system changes and updates from an E2E perspective prior to deployment to the production environment.
  • Provide dedicated E2E operational support to the Steriles Manufacturing Unit (MU), offloading cross-system troubleshooting, partnering with QA, IT, and Manufacturing stakeholders, and serving as a mentor and knowledge center.
Who You Are
  • You hold a Bachelor’s or Master’s degree in Computer Science, Engineering, Information Systems, or a related technical/scientific field.
  • You bring 5+ years of experience in a regulated pharmaceutical or biotech manufacturing environment, operating in strict adherence to GMP, GAMP5, and FDA/EMA regulations.
  • You offer deep functional and technical knowledge of ASPIRE (SAP S/4HANA), MES (e.g., Syncade, Werum PAS-X), and eWM architectures and standard integration patterns.
  • You have a proven track record as a Deviation Owner leading complex RCAs with standard methodologies (e.g., 5 Whys, Fishbone) within systems like Veeva or TrackWise, alongside extensive experience designing and executing multi-system regression testing.
  • You possess the ability to rapidly decipher complex technical dependencies, demonstrate strong crisis-management skills during production stops, and communicate cross-functionally to translate IT issues into actionable business and quality impact statements.
Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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