200+ applicants
Gilead Sciences · 4 days ago
Senior Packaging Engineer I
Foster City, CA
Full-time
Onsite
Senior Level
$133K/yr - $172K/yr
6+ years exp
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Responsibilities
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 Gilead 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.
Qualification
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Required
Prior experience in a cGMP-related industry is highly desirable.
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 Gilead 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.
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 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.
Preferred
Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories is desirable.
Benefits
Company-sponsored medical
Dental
Vision
Life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10,001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (163)
2022 (216)
2021 (218)
2020 (226)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
2017-10-27IPO· bit:GILD
Leadership Team
Patrick Loerch
Senior Vice President, Clinical Data Science
Ahmed Afifi
Vice President - Region Head Latin America
Recent News
http://www.zdnet.com/
2024-05-05
Company data provided by crunchbase
