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, we are committed to enhancing patient lives through innovative healthcare solutions. The Sterile Pharma Suite (StePS) Project is an MES (Manufacturing Execution System) implementation at one of the largest Drug Product (DP) sites globally, aimed at driving digital transformation and optimizing processes in the biopharmaceutical industry.
As the MES Integration Lead, you will play a pivotal role in leading the recipe design, testing, and process execution components of our MES implementation. This role offers a unique opportunity to be a key driver in the digital transformation of sterile pharmaceutical manufacturing. You'll guide your team in aligning business needs to deliver exceptional value while leveraging innovation, industry-leading tools, and methodologies.
The OpportunityPlan and drive the development and delivery of all process requirement specifications (PRS) and high-quality Process Executables (PEX) in alignment with project milestones and in compliance with quality and regulatory standards.
Plan and drive the development, review, and approval process of precise and comprehensive test specifications to validate the functionality of PEX and MES workflows.
Drive the integration of innovative digital solutions in recipe design and process testing to achieve streamlined, efficient, and lean manufacturing workflows.
Ensure all activities related to PRS, PEX, and testing adhere to regulatory and quality standards, including Good Automated Manufacturing Practice (GAMP).
Plan and manage hypercare activities post-implementation and drive the smooth handover of all PEX elements to the lifecycle team.
Coach and empower teams to adopt best-in-class methodologies for recipe design, testing, and process execution.
Act as the leading point of contact among project stakeholders, including QA, Manufacturing, Engineering, and IT teams, to align priorities and achieve project objectives.
Who You Are
MNCJobs.ch will not be responsible for any payment made to a third-party. All Terms of Use are applicable.