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24 days old

Packaging Engineer

Kelly Services
Foster City, CA 94404
Packaging Engineer


Foster City, CA


Up to 77 an hour


6 month contract


This position resides on the Package Development and Operations team which provides technical leadership and expertise in the development, qualification, and implementation of new primary, secondary, and tertiary packaging to meet the needs of Gileads pharmaceutical and biologics pipeline.

Qualified candidates will focus on the development of primary, secondary, and tertiary packaging. They will work collaboratively with Formulation and Process Development, Regulatory Affairs, Clinical Supply Chain Management, and Project Management staff to meet project deliverables such as supplying clinical trial materials for clinical studies.


Specific Job Requirements


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.


Knowledge


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.


Specific Education and Experience 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.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-06-03 Expires: 2022-07-04

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Packaging Engineer

Kelly Services
Foster City, CA 94404

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