• Develop, implement and test new processes and tooling
• Analyze and improve existing manufacturing processes
• Facilitate process development decision making using computer skills for design and analysis (SPC, Statistical Analysis)
• Write and prepare technical reports, qualifications and validations
• Manage business process compliance through process validation, equipment qualification, document control and equipment maintenance
• Maintain materials, tools and facilities necessary for production activities
• Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements
• Develop new manufacturing and design technologies by staying current in areas of focus
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Performs other related duties and responsibilities, on occasion, as assigned