Sr Manager, Industrial Engineering & Process Optimization

Overview In this role you will lead continuous improvement across high-throughput manufacturing, applying industrial engineering methods to increase capacity, reduce cycle times, and improve quality. You will translate floor-level constraints into scalable improvements in collaboration with Manufacturing, Quality, and Automation Engineering. You’ll build data-driven cases to decide between process redesigns, equipment upgrades, or staffing changes, driving operational excellence. This is a hands-on leadership role shaping how we scale biomanufacturing in a regulatory, ISO/GxP environment. ResponsibilitiesAnalyze line performance data to identify capacity and labor utilization bottlenecksInvestigate first pass rate losses and defects; lead root cause analyses with Quality and ManufacturingPrioritize improvement opportunities and evaluate process redesign, equipment, or staffing solutionsBuild ROI models and prepare business cases for improvements including capital requestsDesign and pilot process changes using IE tools (time-motion studies, line balancing, VSM, DOE)Partner with Automation Engineering to scope equipment/automation upgradesCollaborate with Manufacturing and Workforce Planning to optimize staffing without compromising qualityEstablish and track KPIs (OEE, first pass yield, cycle time, cost-per-unit)Ensure changes comply with GxP and collaborate with Quality Assurance on change controlPresent roadmaps and results to senior leadership Key requirements8–12+ years in industrial engineering, continuous improvement, or manufacturing process optimization3–5+ years of supervisory or cross-functional leadershipExperience in ISO 13485 or other GxP-regulated environmentsStrong analytical foundation (OEE, Cpk, takt time, cost-per-unit modeling)Proven ability to influence cross-functional stakeholders without direct authorityHands-on expertise with time-motion studies, line balancing, capacity modeling, and value stream mappingCross-functional collaborationInfluence without formal authorityStrategic thinking and problem solvingOEECpktakt time