6474 - Service Order Packaging Engineer / Project Engineer

Overview:

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.

Requirements:

• Bachelor of Science in Engineering, Materials Science, Industrial Design (or related fields) and/or research and development experience in the pharmaceutical / medical device industry (1-3 years) may substitute.
• Demonstrated quality mindset, ability to influence, and provide project leadership.
• Demonstrated ability to lead cross-functional project assignments.
• Strong interpersonal skills and ability to work productively in an interdisciplinary environment.
• Broad integrated technical knowledge for system and design engineering, product development, and commercialization (packaging, device, etc.).
• Successful interaction with senior technical engineering and scientific personnel.
• Experience working in a diverse networked technical organization with proven skills to manage suppliers and alliance partners.
• Onsite requirement 5 days per week in Indianapolis.