Packaging Engineer II - Foster City, United States - Gilead Sciences, Inc.

Description

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site $) to apply for this job.

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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

This position resides on the Package Development team, which provides technical leadership and expertise in the development, qualification, and implementation of primary, secondary, and tertiary packaging that meets the needs of Gilead's pharmaceutical and biologics pipeline and involves collaboration with Product Development Teams, Regulatory, CMO's, Quality, Suppliers and other involved stakeholders.

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 complex packaging problems.
• Lead packaging activities in support of multiple clinical programs in all phases of development
• Ensure on-time delivery of project deliverables and compliance with current Good Manufacturing Practices (cGMP).
• Execute packaging equipment and process verification and qualification (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 and secondary packaging components (e.g., bottles, blisters, vials, caps, stoppers, labels, and britestock shippers).
• Design and write packaging study protocols and reports that support package qualification, product development, and regulatory filing needs.
• Ensure compliance with international and external regulations.
• Write sections of global regulatory filings related to DDCPE activities.
• Write and review SOPs related to DDCPE activities, ensuring alignment with other Gilead SOPs.
• 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 ofpackage development principles are required. Specific experience in the pharmaceutical/biotechnology sector is preferred.
• Familiarity with applying pharmaceutical packaging standards (e.g., USP, ISO, ASTM).
• Knowledge of FDA and cGMP standards is required.
• Strongverbal, written, and interpersonal communication skills are required.
• Strong computer and organizational skills are required.
• Experience collaborating with external suppliers, contract manufacturing organizations, and contract test laboratories is desirable.

Specific Educationand Experience

• B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field, and a minimum of 4years of relevant industry experience are required. OR
• M.S.. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field, and a minimum of 2years of relevant industry experience are required.
• Prior experience in a cGMP-related industry is highly desirable.

The salary range for this position is: $99, $129, 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.

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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.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.