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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.

Plan 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.

MES Expertise: You have strong knowledge and proven experience in MES Pharma Suite, including recipe design, process execution, and workflow management.

Project Management: You have demonstrated ability to manage complex projects, drive deliverables, and plan activities efficiently.

Regulatory Knowledge: You have a strong understanding of regulatory requirements for sterile pharma manufacturing processes and automation (e.g., GxP, FDA, EU-GMP).

Leadership and Communication: You possess exceptional leadership, coordination, and communication skills, with a proven ability to manage diverse teams and stakeholders effectively.

Preferred Skills: Experience leading MES projects in large, complex pharmaceutical manufacturing sites and familiarity with Kaiseraugst PT site processes and legacy MES (PMX) systems.

A potential candidate has already been identified. Nevertheless, we very much look forward to receiving your application, also with a view to future openings in this area.

The Grade Range for this position is between SE6 and SE7.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

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.