Ensure there is a technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.
- Lead the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment.
- Coordinate and support PET’s Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence to manage life cycle of assets.
- Maintain external technical relationships and collaborates with equipment and material suppliers.
- Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
- Perform and maintain risk management activities for new and existing processes / equipment.
- Initiate deviations and performs or facilitates the technical investigations and assessment of impacts.
- Author and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms.
- Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests.
- Assist in the development of project justification and engineering proposals including providing input for capital planning process.
- Identify and support technical training requirements for operations, Engineering or Maintenance for new and existing processes or equipment.
- Perform routine validation and periodic reviews activities; Participates in annual product review process, biennial critical systems review process and responsible for process validation required as a result of changes to validated processes within the PET.
- Work collaboratively within PET as well as with other PET Engineers and Technology Community i.e. Technology and Engineering, global colleagues.
