Senior Packaging Engineer I

This position resides on the Package Development and Operations team, which develops primary, secondary, and tertiary packaging that meets the needs of the pharmaceutical and biologics pipeline.  This position will have responsibilities in three areas:

• Controlled Temperature Shipping Containers
• Primary and Secondary Package Development for oral solid dose and parenteral products.
• Combination product packaging

Prior experience in a cGMP-related industry is required.

 Specific Job Requirements

• Deliver technical leadership in temperature-controlled shipping containers, identify solutions to meet stakeholder needs, partner with suppliers to design solutions, execute qualification studies, and author related protocols and reports.
• Partner with stakeholders to establish the infrastructure necessary to bring shipping container solutions into service.
• Provide expertise in developing processes related to combination products.
• Lead packaging activities supporting multiple clinical programs in all phases of development, ensuring on-time delivery of project deliverables and compliance to current Good Manufacturing Practice (cGMP).
• Execute packaging equipment and process verification and validation (including IQ/OQ/PQ studies) to prove the effectiveness of new packaging configurations and/or packaging lines/sites.
• Support packaging operations and drive expeditious and appropriate resolution of deviations and investigations as necessary.
• Perform characterization and qualification of primary packaging components (e.g., bottles, blisters, vials, prefilled syringes, caps, stoppers).
• Write and review SOPs related to DDCPE activities, ensuring alignment with other company     SOPs.
• Design and write packaging study protocols and reports that support product development and regulatory filing needs.
• Write sections of global regulatory filings related to DDCPE activities.
• Train new employees in SOPs and documentation systems.
• Overnight travel may be required up to 25% of the time.

Knowledge

• Excellent technical skills and knowledge of package development principles are required.  Specific experience in the biotechnology sector is highly desired.
• A detailed understanding of component and line qualification is required.
• Knowledge of temperature-controlled shipping container qualification following ISTA 7D is required.
• Knowledge of combination product packaging and associated regulations and familiarity with design controls.
• Knowledge of FDA and cGMP standards is required.
• Strong verbal, written, and interpersonal communication skills are required.
• Strong computer and organizational skills are required.
• Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories is desirable.

Basic Qualifications:

• B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field, and a minimum of 6+ years of relevant industry experience is required. 
• Advanced degree(s) with commensurate industry experience is also considered.