Senior Principal MES Engineer (CVRM)

ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at nine sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).  

The Opportunity

A Senior Principal MES Engineer/ Leader is being hired to participate in Greenfield Project execution and then support the facility after going live.

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

What You’ll Do

The Senior Principal MES Engineer will be responsible for providing Manufacturing Execution Systems (Pharmasuite MES) capabilities and experience to the ITOT / MES Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the manufacturing execution systems for process, utility and building systems as appropriate. Lead MES impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes.
 

• MES System implementation including System architecture components and Recipe Authoring for drug product manufacturing processes in GMP environment

• Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and Global MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors. 

• Produce and review design specification documents (URS,PRS,FS, DS, etc.). 

• Support end-to-end system qualification, including test creation, execution, review and approval.

• Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.

• Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings. 

• Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes.

• Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans). 

• Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines. 

• MES lead for equipment/software FAT, SAT,  field testing and commissioning

• Provide scope, qualification, resource, and budget estimates for MES impacting projects.

• Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team.  

• Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.

• Provide input into network/global business processes and procedures (e.g. GSPs). 

• All employees with jobs that require access to the