Senior MES Engineer, CVRM (Holly Springs)
Genentech · Charlotte, North Carolina, United States
Hybrid Full-time Posted 4 days ago
About this role
<h3>The Position</h3><h2>The Opportunity</h2><p></p><p><span>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 9 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 Springs, 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). </span></p><p></p><p><span>The Sr MES Engineer is being hired to participate in Greenfield Project execution and subsequently support the facility after going live
Focus of the role is Pharmasuite recipe authoring with expectation to grow in MES beyond authoring.</span></p><p></p><p><span>Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at the construction site/plant). You will transition to local full-time on-site work once site buildings are constructed and equipment is delivered. Travel of up to 30% is expected during the project phase.</span></p><p></p><p><b>What You’ll Do</b></p><p><span>This role provides Manufacturing Execution Systems (Rockwell PharmaSuite) capabilities to the ITOT/MES Group, including generating qualification protocols and maintaining the validated state of systems.</span></p><ul><li><p><span>Initial Project Focus: Participate in Basic Design,
Apply for this role on Genentech’s official careers site.