Packaging Engineer III

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Key Responsibilities

• Execute packaging development activities supporting product development and clinical study supplies across OSD biologics and combination products.

• Apply pharmaceutical packaging principles to support the development characterization and qualification of primary secondary and tertiary packaging systems including container closure and distribution packaging.

• Support packaging activities through regulatory submission ensuring documentation and data meet internal quality standards and global regulatory expectations.

• Perform component characterization and qualification for packaging materials and components including bottles blisters sachets cartons labels and shipping systems.

• Execute and document shipping qualification activities supporting development and regulatory filings including biologics shipping data bulk and britestock shipments finished goods distribution for OSD products parenteral products and combination products.

• Support execution and documentation of packaging equipment and process qualification activities (IQ/OQ/PQ) in collaboration with internal manufacturing teams and CMOs.

• Provide technical support to packaging and clinical supply operations including participation in deviation investigations change controls and issue resolution.

• Collaborate crossfunctionally with internal teams CMOs suppliers and contract test laboratories to support packaging deliverables.

• Author and review technical documentation including protocols reports and regulatorysupporting content using established templates and procedures.

• Ensure assigned work is completed on time and in compliance with cGMP GDP and applicable regulatory and quality system requirements.

• Contribute to knowledge sharing onboarding and continuous improvement efforts within the packaging development organization.

Knowledge Skills and Abilities

• Practical working knowledge of pharmaceutical packaging development including container-closure systems and distribution packaging.

• Experience supporting OSD packaging systems such as bottles and blisters including moisture and lightsensitive products.

• Working familiarity with packaging requirements for biologics and drugdevice combination products including container closure integrity and product protection considerations.

• Ability to execute component characterization qualification and packaging studies including shipping and distribution qualifications.

• Understanding of cGMP principles and global regulatory expectations applicable to pharmaceutical packaging.

• Familiarity with applicable industry standards and test methods (e.g. USP ISO ASTM).

• Ability to author and review technical documentation using established templates and guidance.

• Effective collaboration skills for working in crossfunctional and matrixed environments including interaction with CMOs suppliers and contract test laboratories.

• Strong organizational and timemanagement skills with the ability to manage multiple assignments and meet project timelines.

• Strong written and verbal communication skills and sound engineering judgment.

• Overnight travel may be required up to 20% of the time.

Basic Qualifications:

• Bachelors degree in Packaging Engineering Mechanical Engineering Biomedical Engineering Chemical Engineering Industrial Engineering or a related scientific field and a minimum of 5 years of relevant industry experience.

OR

• Masters degree in Packaging Engineering Mechanical Engineering Biomedical Engineering Chemical Engineering Industrial Engineering or a related scientific field and a minimum of years of relevant industry experience.

• Advanced degree(s) with commensurate industry experience will be considered.

• Prior experience in a cGMPregulated pharmaceutical or biotechnology industry is highly desirable.

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:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 theKnow Your Rights poster.

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

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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 apply via the Internal Career Opportunities portal in Workday.