Manufacturing System Engineer (PI System Owner)
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
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.
Your Key Responsibilities
Take over the responsibility as a local System Owner for Data Historian/RMS 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. MES 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
Who You Are
Bachelor’s degree in IT or Engineering (Computer/Automation Engineering preferred) + Minimum 5 years of experience in system and/or network administration
Pharmaceutical or similar Manufacturing domain knowledge
Several years of deep experience with Data Historians, best with Aveeva PI
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.
This position is not eligible for relocation.
Full time or Part time are considered for this position (70% up to 100%)
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
