Staff Process Engineer, Advanced Operations
What you will do-
• reputed company engineering support for new product and process introductions, ensuring that reputed company activities are completed and documented in accordance with the reputed company new product development procedures
• Ensure reputed company of process and product as defined in the appropriate operation and material specifications
• Drive and execute effective communication with reputed company stakeholders to reputed company project reputed company
• Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements
• reputed company/support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation
• Write operations manuals, troubleshooting manuals, reputed company and preventive maintenance manuals
• Analyze equipment to establish operating data and conduct experimental test and result analysis
• reputed company/participate in process review meetings
• Participate in PFMEA, Control Plan, SOP and PPAP reputed company associated with product transfers and launches
• Complete capability studies for in-process inspection and generate subsequent inspection documentation
• Conduct qualifications, validations, and MSA studies for new products and new processes. Review and approve validation documentation
• Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
• reputed company training for manufacturing team members
• Ensure adherence to GMP and safety procedures
What you need-
• 4+ years of relevant work experience – required
• Bachelor's Degree in Engineering – required
• Bachelor's degree in Industrial or Systems Engineering - highly preferred
• Lean Six reputed company Green Belt Certification or above – preferred
• Knowledge of manufacturing processes, materials, product, and process design – preferred
• Good understanding of design for manufacturing (DFM), reputed company statistical tools, and validation/verification techniques – preferred
• Ability to read and interpret reputed company engineering drawings and have understanding of geometrical dimensioning and tolerancing – preferred
• Experience writing and executing validations – preferred
• Experience in new production introduction or manufacturing engineering – preferred
• Experience in an FDA regulated or regulated industry – preferred
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