Process Engineer
Core
Lead process improvement projects for silicone product manufacturing, optimizing production rates, efficiencies, yields, and quality performance while ensuring compliance with cGMP and ISO regulations.
Role type
Senior Process Engineer (Chemical Manufacturing)
Builds
Production equipment, new manufacturing processes, and process optimization systems for silicone biochemicals and reagents.
Domain
Chemical manufacturing / Life Science reagents
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process design, scale-up, site transfer, NPI process for manufacturability, Root Cause Analysis (RCA), PFMEA, equipment sizing and selection, project management (Agile/Waterfall), SAP Hana ERP, DMAIC, Six Sigma, lean manufacturing, 5S, GMP compliance, regulatory knowledge (cGMP, ISO, FDA, 21 CFR Part 820)
Preferred skills
NuSil processes knowledge, GMP manufacturing environment experience, Advanced Excel (macros, pivot tables), CAD/Solid Works, Visual Basic, OSHA/NFPC/HazWoper knowledge
Technologies
SAP Hana, Agile, Waterfall, Excel, CAD, Solid Works, Visual Basic
Responsibilities
Implement process improvements and feasibility studies, create master recipes and process documentation, analyze manufacturing data to monitor processes, lead RCA and PFMEA to prevent recurrence, manage design calculations and equipment validation, interact with customers/vendors to develop specifications, develop new manufacturing processes and assess equipment adequacy, design and commission new production equipment, manage project budgets for equipment procurement, support manufacturing and maintenance efforts, lead reliability improvement efforts and downtime analysis.
Seniority
Senior, hands-on IC
