San Mateo, CA

Packaging Engineer

Job Description

Responsibilities:

Deliver expertise in applying pharmaceutical packaging principles and testing methodologies related to container closure systems.
Develop innovative, thorough, and practicable solutions to a wide range of complex packaging problems.
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.
Select and perform characterization and qualification of primary and secondary packaging components (e.g., bottles, blisters, vials, caps, stoppers, labels, and shippers).
Design and write packaging protocols and reports that support product development and regulatory filing needs.
Author sections of global regulatory filings related to container closure systems.
Write and review SOPs related to DDCPE activities, ensuring alignment with other Gilead SOPs.
Overnight travel may be required up to 20% of the time.

Requirements:

B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 5 years of relevant industry experience is required. Advanced degree(s) with industry experience is also considered.
Prior experience in a cGMP-related industry is highly desirable.
Excellent technical skills and knowledge of package development principles are required. Specific experience in the pharmaceutical/biotechnology industry is preferred.
Expertise in applying pharmaceutical packaging standards (e.g., USP, ISO, ASTM).
Knowledge of FDA and cGMP standards is required.
Strong verbal, written, and interpersonal communication skills are required.
Must be able to write clear, concise and error-free documents.
Strong computer and organizational skills are required.
Experience collaborating with external suppliers, contract manufacturing organizations, and contract test laboratories is desirable.

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