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    Senior Packaging Engineer I - Foster City, United States - Gilead Sciences

    Gilead Sciences
    Gilead Sciences Foster City, United States

    1 week ago

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    Description

    Job Description

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

    We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

    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

    • Prior experience in a cGMP-related industry is 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.

    • Knowledge

  • 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 temperature-controlled shipping container qualification following ISTA 7D 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.
  • Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories is desirable.

    • Basic Qualifications:

  • 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.
    • The salary range for this position is: $133, $172, 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*.
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