Senior Manufacturing Project Engineer
Senior Manufacturing Project Engineer - $100-110K + Bonus ? Pharmaceuticals & Biotech Manufacturing - Responsible for oversight of manufacturing engineering projects including: design modifications of machinery and equipment, specification and procurement of new equipment and tooling, equipment installation and start-up, and supervision of team members (which can include CAD operators, mechanics, and electricians). Manage manufacturing engineering projects from conception through completion: Interpret equipment capabilities and specifications. Define equipment required to achieve optimal production. Prepare detailed project descriptions. Prepare sketches and design layout. Prepare BOMs, schematics and cost estimates. Prepare and manage schedules. Vendor selection and procurement of new equipment/tooling. Project budgeting. Manages installation and modifications. Start-up and training. Investigate equipment performance and identify any problems for corrective actions and solutions. Work closely with all internal team members to identify issues and implement improvements (i.e. machine design, tooling, modifications, new equipment, etc.). Writes/revises SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, Qualifications, etc. Executes Factory and Site Acceptance Tests, Machinability Studies, and validation protocols. Writes and executes Risk Analysis (i.e. FMEA and Fishbone Diagrams) and Engineering Change Orders. Maintain GMP compliance. Utilize continuous improvement methodology to improve internal processes.
Bachelor's Degree (engineering discipline). 5-10 years' engineering experience. Capital project management experience. Experience with equipment/machinery installation and start-up (packaging equipment highly preferred). Good computer skills; experience with AutoCAD and/or SolidWorks. Experience from FDA or other highly regulated environment. Pharmaceutical industry highly preferred. Attention to detail. Self-motivated and driven individual. Excellent interpersonal and communication skills