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    Senior Packaging Engineer I - Foster City, United States - Taleo BE

    Taleo BE
    Taleo BE Foster City, United States

    3 weeks ago

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    Description
    For Current Gilead Employees and Contractors:

    Please log onto your

    Internal Career Site

    to apply for this job.

    At Gilead we believe every employee deserves a great leader.

    As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

    Job Description

    At Gilead we believe every employee deserves a great leader.

    As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

    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 Gilead's 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

    Pr io r

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    pe r ie

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    M P-r ela t e d

    i

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    us try

    i s highly desirable.

    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 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.

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    no

    w

    ledg e

    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.

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    is required .

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    l s are required.

    Str on g

    co

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    pu t e r and organizational

    s

    ki

    l

    l s are required.

    Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories is desirable.


    Basic Qualifications:
    B.S.

    degree

    i n

    industrial engineering,

    mechanical engineering, biomedical engineering, chemical engineering, package engineering, o r a r e

    l

    a t e d

    s

    ci

    e

    n t i

    f

    i c

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    el d,

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    of 6+

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    ea rs

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    an t

    industry

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    x

    pe r ienc e is required.

    A dvanced degree(s) with commensurate industry experience is also considered.


    The salary range for this position is: $129, $167, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

    These considerations mean actual compensation will vary.

    This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

    Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

    For additional benefits information, visit:

    • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
    For jobs in the

    United States:
    As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or

    mental

    disability, genetic


    information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

    In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact

    for assistance.

    For more information about equal employment opportunity protections, please view the

    'Know Your Rights'

    poster.


    NOTICE:

    EMPLOYEE POLYGRAPH PROTECTION ACT
    YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

    PAY TRANSPARENCY NONDISCRIMINATION PROVISION
    Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
    Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

    For Current Gilead Employees and Contractors:

    Please log onto your

    Internal Career Site

    to apply for this job.

    #J-18808-Ljbffr
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