IT OT Manufacturing System Engineer

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

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.

About the role:

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market? Then this role might be for you!

As part of the Kaiseraugst IT OT team, you will report to the Business Integration Management Lead and take the local System Ownership accountabilities for Data Historian/Room Monitoring System and potentially other Systems. You will ensure the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.

The Opportunity:

• Take over the responsibility as a local System Owner for the local Manufacturing Execution Systems (MES) and potentially other Systems in a 24x7 Good Manufacturing Practice (GMP) environment

• Responsible for the overall development, integration, modification, operation, maintenance, validation, and retirement of systems in charge

• Perform system periodic reviews

• Work with Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.

• Represent and mitigate application dependencies as related global systems evolve their business processes and technologies (e.g. PI upgrade & LIMS replacement).

• Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.

• Participation in audits & inspections

• Possible 7x24 stand by duty

Who You Are:

• Bachelor’s degree in IT or Engineering (Computer/Automation Engineering preferred)

• Minimum 5+ years of experience in system, data base (MS SQL) and network administration

• Expert knowledge and hand on experience as MES System Engineer or MES Application Manager of Pharma Suite and PMX for Rockwell Automation

• Deep knowledge in interface management (PI Data Historian, LIMS and ERP)

• Knowledge in monitoring solutions (Logicmonitor, Paessler PRTG)

• Several years project management experience

• Pharmaceutical or similar manufacturing domain knowledge

• Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment

• Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA)

• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles

• Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.

• English and German speaking (min B2)

This position is not eligible for relocation.

Full time are considered for this position (100%)

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.