Packaging Engineer - Lead

· Ability to evaluate existing packaging formats and packaging operations to improve productivity and initiate cost savings projects.

· Originate change controls and events to support packaging material changes that effect operations

· Understand the packaging requirements for international shipments, including dangerous goods and UN certification.

· Interface with internal teams and external suppliers to conduct packaging testing (including shipping validations) of packaging materials and packaged components.

· Support the process qualification and validation of packaging equipment on key projects that evaluates the new or modified packaging components at sites.

· Provide guidance regarding technical protocols and reports for primary, secondary and tertiary packaging components and associated qualifications and/or validations.

· Experience with process qualification and validation across various packaging technologies within pharmaceutical packaging formats (blisters, bottles, bags, sachets, cartons, form fill seal, parenteral, etc.)

· Accountable for updating and maintaining packaging specifications as required to support packaging operations at CMs. This would include primary, secondary and tertiary packaging components, ensuring that all products are compliant with RCD (Regulatory Commitment Documents).

· Author, review and approve packaging instructions as applicable

· Awareness of industry and regulatory developments with respect to packaging materials.

· Support the packaging artwork change process by providing the appropriate dimensional templates for packaging components (cartons, labels, bags, etc.) that allows the art studio to layout the text and graphics properly on the packaging component.

· Provide guidance around the design and selection of primary, secondary and tertiary packaging components and suppliers.

· Support the Audit group in auditing of Packaging manufacturers and suppliers.