|Description Main Objective: Provide manufacturing process engineering expertise in the areas of clean-room /and or production work flow optimization, productivity efficiency, work cell layout, work measurement and process implementation for sterile product packaging operations.
Essential Duties and Responsibilities:
Provide process and equipment expertise and support for daily clean-room sterile packaging efforts/and or production efforts.
Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation.
Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
Develop an understanding of the current manufacturing processes and identify targets for improvement in operation efficiencies.
Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
Provide process support on manufacturing technical issues.
Develop protocols and coordinate validation of equipment and processes.
Develop manufacturing SOPs and Workstation Instructions for good manufacturing practices.
Stay current with methods used in the medical device industry to advance technologies.
Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Requirements Education and Experience:
Four year degree as Mechanical, Manufacturing, Industrial or Packaging Engineer.
3-5 years Process Engineering experience with proven experience in the areas of work flow optimization, productivity efficiency and work measurement, preferably from pharmaceutical or medical device environment.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Basic understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Familiar with clean room practices.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
Machine, Tools, and/or Equipment Skills:
Label printing equipment; pouch and blister sealing equipment; custom tool fixturing - some with electro/mechanical or pneumatic activation.
State or Province