Gilead
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
The Senior Packaging Engineer I serves as a technical leader within the Package Development team, responsible for the design, qualification, and implementation of packaging systems supporting Gilead’s pharmaceutical and biologics pipeline. This role is essential for developing packaging solutions for combination products, device-integrated therapies, and temperature-sensitive and conventional dosage forms. The successful candidate will bring strong expertise in packaging engineering, regulatory compliance, and cross-functional collaboration to ensure packaging systems meet product, patient, and global regulatory requirements.
Specific Job Requirements
Lead the development and qualification of
primary, secondary, and tertiary packaging systems
for oral solids, parenteral, biologics, and combination products.
Apply advanced principles related to
container closure systems (CCS)
and
drug/device secondary packaging , ensuring robust design and operational performance.
Manage packaging activities across
clinical development and commercialization , ensuring timely execution and compliance with
cGMP
and regulatory standards.
Support
combination product packaging , demonstrating familiarity with
design controls , risk management, and applicable regulations (e.g., 21 CFR Part 4, ISO 11607).
Manage
material selection , component characterization, and qualification of packaging systems and equipment.
Execute
equipment and process qualification
(IQ/OQ/PQ) for packaging configurations and manufacturing sites.
Design and author
packaging study protocols and technical reports
to support product development, stability, and regulatory submissions.
Draft and review
Standard Operating Procedures
( SOPs ) related to packaging development and departmental functions, ensuring alignment with broader organizational policies.
Contribute to
global regulatory filings
by authoring packaging-related sections for INDs, NDAs, BLAs, and other submissions.
Collaborate cross-functionally with
Regulatory, Quality, Supply Chain, Device Engineering , and external partners to develop and implement optimal packaging solutions.
Monitor
industry trends , emerging technologies (e.g., sustainable packaging), and evolving regulatory requirements.
Participate in
standards organizations
(e.g., USP, ISO, ASTM, ISTA) and contribute to internal packaging policy development.
Demonstrate
familiarity with temperature-controlled shipping container qualification , including ISTA 7D methodology and supplier engagement.
Lead or contribute to
strategic initiatives
aimed at enhancing packaging capabilities and compliance.
Mentor
or manage junior packaging engineers and serve as a technical lead on cross-functional teams.
Train new employees on SOPs, documentation systems, and packaging best practices.
Support packaging operations by resolving
deviations and investigations
in collaboration with Quality and Operations.
Initiate and manage
change controls
related to packaging systems and documentation.
Travel up to
20%
may be required to support external site activities and supplier collaboration.
Knowledge Requirements
Strong technical expertise in
packaging engineering and development methodologies , with experience across biologics and traditional pharmaceutical dosage forms (e.g., oral solids, powders, suspensions, small molecules, and parenterals).
Familiarity with
combination product packaging , including applicable regulatory requirements and
design control principles .
Working knowledge of
FDA, cGMP , and global regulatory guidance related to
container closure systems
and
temperature-controlled packaging .
Proven ability to collaborate with
external suppliers ,
contract manufacturing organizations (CMOs) , and contract test laboratories.
Strong
written, verbal, and interpersonal communication skills , with the ability to clearly document and present technical work.
Proficient in
project management , organizational planning, and use of relevant software tools for documentation and analysis.
Demonstrated ability to exercise
sound engineering judgment
in a fast-paced, dynamic environment.
Experience supporting packaging activities at
pharmaceutical CMOs
is highly desirable.
Basic Qualifications:
Doctorate OR
Master’s and 4+ years of relevant experience in a cGMP-related industry OR
Bachelor’s and 6+ years of relevant experience in a cGMP-related industry
Preferred Qualifications:
Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field
Proven experience in a
cGMP-compliant environment , with a strong understanding of regulatory expectations for pharmaceutical and biologics packaging.
Hands-on experience in
packaging development for injectable biologics, combination products , and
temperature-sensitive pharmaceuticals .
Familiarity with
TAPPI ,
ISTA , and
ASTM
standards for packaging materials and systems, including mechanical and environmental testing protocols.
Demonstrated experience with
CAD-based packaging assembly drawings , development of
protective and user-friendly secondary packaging features , and implementation of
moisture barrier packaging solutions
for sensitive pharmaceutical and biologic products.
Experience using
electronic documentation systems
such as
Veeva
and
TrackWise
for managing quality and regulatory documentation.
Prior involvement in
shipping qualification
for biologic and combination products, including
thermal and mechanical validation . Experience supporting
technology transfer ,
component qualification , and
design history file (DHF)
development, including
design inputs ,
verification ,
validation , and
human factors engineering (HFE)
in alignment with
FDA and ISO standards .
Active participation in professional organizations (e.g.,
PDA ,
ISPE ,
IoPP ) or contributions to industry publications and conferences.
Experience leading or contributing to
sustainable packaging initiatives , including material selection, recyclability, and life cycle assessments (LCA).
The salary range for this position is: $136,340.00 - $176,440.00. 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 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 ApplicantAccommodations@gilead.com 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 apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr
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
The Senior Packaging Engineer I serves as a technical leader within the Package Development team, responsible for the design, qualification, and implementation of packaging systems supporting Gilead’s pharmaceutical and biologics pipeline. This role is essential for developing packaging solutions for combination products, device-integrated therapies, and temperature-sensitive and conventional dosage forms. The successful candidate will bring strong expertise in packaging engineering, regulatory compliance, and cross-functional collaboration to ensure packaging systems meet product, patient, and global regulatory requirements.
Specific Job Requirements
Lead the development and qualification of
primary, secondary, and tertiary packaging systems
for oral solids, parenteral, biologics, and combination products.
Apply advanced principles related to
container closure systems (CCS)
and
drug/device secondary packaging , ensuring robust design and operational performance.
Manage packaging activities across
clinical development and commercialization , ensuring timely execution and compliance with
cGMP
and regulatory standards.
Support
combination product packaging , demonstrating familiarity with
design controls , risk management, and applicable regulations (e.g., 21 CFR Part 4, ISO 11607).
Manage
material selection , component characterization, and qualification of packaging systems and equipment.
Execute
equipment and process qualification
(IQ/OQ/PQ) for packaging configurations and manufacturing sites.
Design and author
packaging study protocols and technical reports
to support product development, stability, and regulatory submissions.
Draft and review
Standard Operating Procedures
( SOPs ) related to packaging development and departmental functions, ensuring alignment with broader organizational policies.
Contribute to
global regulatory filings
by authoring packaging-related sections for INDs, NDAs, BLAs, and other submissions.
Collaborate cross-functionally with
Regulatory, Quality, Supply Chain, Device Engineering , and external partners to develop and implement optimal packaging solutions.
Monitor
industry trends , emerging technologies (e.g., sustainable packaging), and evolving regulatory requirements.
Participate in
standards organizations
(e.g., USP, ISO, ASTM, ISTA) and contribute to internal packaging policy development.
Demonstrate
familiarity with temperature-controlled shipping container qualification , including ISTA 7D methodology and supplier engagement.
Lead or contribute to
strategic initiatives
aimed at enhancing packaging capabilities and compliance.
Mentor
or manage junior packaging engineers and serve as a technical lead on cross-functional teams.
Train new employees on SOPs, documentation systems, and packaging best practices.
Support packaging operations by resolving
deviations and investigations
in collaboration with Quality and Operations.
Initiate and manage
change controls
related to packaging systems and documentation.
Travel up to
20%
may be required to support external site activities and supplier collaboration.
Knowledge Requirements
Strong technical expertise in
packaging engineering and development methodologies , with experience across biologics and traditional pharmaceutical dosage forms (e.g., oral solids, powders, suspensions, small molecules, and parenterals).
Familiarity with
combination product packaging , including applicable regulatory requirements and
design control principles .
Working knowledge of
FDA, cGMP , and global regulatory guidance related to
container closure systems
and
temperature-controlled packaging .
Proven ability to collaborate with
external suppliers ,
contract manufacturing organizations (CMOs) , and contract test laboratories.
Strong
written, verbal, and interpersonal communication skills , with the ability to clearly document and present technical work.
Proficient in
project management , organizational planning, and use of relevant software tools for documentation and analysis.
Demonstrated ability to exercise
sound engineering judgment
in a fast-paced, dynamic environment.
Experience supporting packaging activities at
pharmaceutical CMOs
is highly desirable.
Basic Qualifications:
Doctorate OR
Master’s and 4+ years of relevant experience in a cGMP-related industry OR
Bachelor’s and 6+ years of relevant experience in a cGMP-related industry
Preferred Qualifications:
Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field
Proven experience in a
cGMP-compliant environment , with a strong understanding of regulatory expectations for pharmaceutical and biologics packaging.
Hands-on experience in
packaging development for injectable biologics, combination products , and
temperature-sensitive pharmaceuticals .
Familiarity with
TAPPI ,
ISTA , and
ASTM
standards for packaging materials and systems, including mechanical and environmental testing protocols.
Demonstrated experience with
CAD-based packaging assembly drawings , development of
protective and user-friendly secondary packaging features , and implementation of
moisture barrier packaging solutions
for sensitive pharmaceutical and biologic products.
Experience using
electronic documentation systems
such as
Veeva
and
TrackWise
for managing quality and regulatory documentation.
Prior involvement in
shipping qualification
for biologic and combination products, including
thermal and mechanical validation . Experience supporting
technology transfer ,
component qualification , and
design history file (DHF)
development, including
design inputs ,
verification ,
validation , and
human factors engineering (HFE)
in alignment with
FDA and ISO standards .
Active participation in professional organizations (e.g.,
PDA ,
ISPE ,
IoPP ) or contributions to industry publications and conferences.
Experience leading or contributing to
sustainable packaging initiatives , including material selection, recyclability, and life cycle assessments (LCA).
The salary range for this position is: $136,340.00 - $176,440.00. 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 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 ApplicantAccommodations@gilead.com 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 apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr