Essential Duties:
- Executes packaging line operations, processes and procedures.
- Coordinates the packaging efforts for designated production lines and teams.
- Completes machine set up, operations, tooling changes, adjustments and troubleshooting related to the operation of one or more packaging lines.
- Assists in maintaining line efficiencies and standards to meet quality packaging requirements and established routing times.
- Tyvek sealers
- Development and execution of validation plans
- Monitoring of the process of sealing sterile barrier packaging
- Medical device tray sealing. tray sealing process as well as the standard sencorp bar sealing of pouches.
- May participate in the training of new team members or retraining for current team members to ensure all standard operating procedures are followed, as written.
- Maintains appropriate quality and production documentation. Responsible for the review of all assigned batch record documentation to ensure error free work.
- Performs general, light maintenance and troubleshooting of machines and related equipment.
- Reviews daily production compared to defined routings and identifies ideas for continuous improvement.
- Participates in activities associated with collaboration with Technical Services, Maintenance and Engineering departments with new equipment and equipment qualifications.
- Ensures a safe work environment and that team members are performing job duties in accordance with all safety requirements and guidelines.
- Demonstrates and works in accordance with Corporate Values. Demonstrates the ability to promote these values to Packaging team members.
Education and Experience Requirements: Bachelor's degree and a minimum of 3 years experience working in a manufacturing, packaging or maintenance/mechanical environment. Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures.