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Senior Packaging Engineer I
Foster City, CA

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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 our clients' pharmaceutical and biologics pipeline.  This position will have responsibilities in three areas:

  • Controlled Temperature Shipping Containers
  • Clinical Labeling Technical Analysis
  • Primary and Secondary Package Development.

 

Specific Job Requirements

  • Deliver technical leadership in temperature-controlled shipping containers, identify solutions to meet stakeholder needs, partner with suppliers to design solutions, and execute qualification studies and authoring related reports.
  • Partner with stakeholders to establish the infrastructure necessary to bring shipping container solutions into service.
  • Supply technical expertise related to clinical label manufacture, evaluate change requests pertaining to substrates, inks, adhesives, manufacturing processes, etc., perform tests, and implement changes. 
  • 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 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 preferred.
  • A detailed understanding of the qualification process is required.
  • Knowledge of temperature-controlled shipping containers is highly desirable.
  • 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.

 

Specific Education and Experience

  • 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.
  • Prior experience in a cGMP-related industry is highly desirable.

 

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