6474 - Service Order Packaging Engineer / Project Engineer

The role of a Packaging Engineer in a product development setting may be focused on one or more of the following activities:

Developing primary and critical secondary container-closure systems (CCS) for finished / bulk drug products (parenteral / oral), and drug substances

Developing secondary packaging for drug products, combination products, and devices

Process engineering for packaging process development

Shipping & distribution packaging development

Service Order Packaging Engineer Responsibilities:

Plans and executes key activities to support the design, characterization, and qualification of packaging components, container closure systems, secondary packaging, shippers for distribution, and filling processes in accordance with PR&D and PDS quality system procedures, as applicable.

Partners with key stakeholders (internal and external stakeholders) to enable project progression from clinical development through commercialization.

Designs and leads the execution of studies to develop packaging component specifications, incoming testing methods, secondary packaging structures (carton, tray, printed materials, labels, adhesives), and/or filling profiles/processes.

Assists in the evaluation, development, and implementation of new packaging or filling technology solutions, to achieve project development and commercialization milestones.

Conducts risk assessments to evaluate components, systems, suppliers, product distribution, and/or processes.

Supports shipping characterization studies for both drug substances and drug products.

Evaluates and communicates the impact of supplier change notifications on drug substance and drug product packaging and regulatory commitments.

Interfaces with suppliers as needed to understand component availability and application to relevant molecule projects.

Supports the authoring and technical review of documentation including protocols, technical reports, control strategy, development history, and regulatory submission documentation.

Stays abreast of regulatory and compendial requirements for packaging components and systems.

Supports the technical transfer activities associated with implementing packaging systems solution across projects to enable clinical delivery and registration stability/process validation at commercial manufacturing operations (internal/external)

Partners with Device development, Business Unit, and Human Factor teams to drive patient-centered packaging design requirements.

Maintain area in a state of regulatory inspection readiness.