Gilead Sciences
Associate Packaging Engineer
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Associate Packaging Engineer at Gilead Sciences. This entry-level position is ideal for a recent graduate eager to begin a career in the pharmaceutical, biologics, and combination product industry. The successful candidate will contribute to the design, development, and qualification of packaging systems that ensure product protection, patient safety, and compliance with global regulatory standards. This role offers hands-on experience across the product lifecycle—from early-phase clinical development through commercial launch. Key Responsibilities
Serve as a Packaging Development representative on cross-functional product development teams, supporting container closure system selection and development from Phase 1 through commercial transfer. Collaborate with internal stakeholders and external contract manufacturing organizations (CMOs) to coordinate clinical packaging operations and provide technical support, including on-site troubleshooting. Assist in the evaluation, characterization, and qualification of primary, secondary, and tertiary packaging components (e.g., vials, stoppers, syringes, blisters, bottles, caps, cartons, trays, shippers). Design, author, and execute packaging development protocols, test plans, and technical reports in accordance with internal procedures and regulatory expectations. Support packaging equipment and process qualifications (IQ/OQ/PQ) and participate in packaging line trials under supervision. Conduct hands-on testing and documentation activities in the packaging development laboratory, including sample preparation and data collection. Author and maintain packaging specifications, bills of materials (BOMs), and other technical documentation within document control systems. Support regulatory submissions by providing packaging-related documentation and data for INDs, NDAs, BLAs, and other filings. Participate in risk assessments (e.g., FMEA) related to packaging systems and processes. Assist in change control activities related to packaging components and specifications. Support sustainability initiatives by evaluating and recommending environmentally responsible packaging solutions. Maintain compliance with internal quality systems and participate in audits or inspections as needed. Travel to CMOs, suppliers, and other sites as needed to support packaging operations, qualifications, and issue resolution. Basic Qualifications
Bachelor’s OR Associate and 2+ years of relevant experience OR High School Diploma/GED and 3+ years of relevant experience Preferred Qualifications
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related scientific discipline. Strong foundational knowledge of packaging principles, materials, and engineering practices. Excellent written and verbal communication skills, with the ability to produce clear, concise, and accurate technical documentation. Proficiency in Microsoft Office and familiarity with document management systems. Strong organizational skills and attention to detail. Familiarity with FDA regulations, current Good Manufacturing Practices (cGMP), and United States Pharmacopeia (USP) standards. Interest in and basic proficiency in Computer-Aided Design (CAD) tools. Familiarity with design controls and human factors engineering principles. Exposure to materials science, thermal testing, or transport simulation methods is beneficial. Experience with labeling development and serialization requirements is a plus. Basic understanding of ISO 11607, ICH guidelines, or EU MDR is helpful. Ability to work effectively in a team-oriented, fast-paced environment. Preferred Attributes
Eagerness to learn and grow within a regulated industry. Collaborative mindset with a proactive approach to problem-solving. Willingness to travel and engage with cross-functional teams and external partners. Compensation and Benefits
The salary range for this position is: $82,195.00 - $106,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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
For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity
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. For Current Gilead Employees And Contractors, please apply via the Internal Career Opportunities portal in Workday. Seniority level: Not Applicable Employment type: Full-time Job function: Engineering and Information Technology Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Associate Packaging Engineer at Gilead Sciences. This entry-level position is ideal for a recent graduate eager to begin a career in the pharmaceutical, biologics, and combination product industry. The successful candidate will contribute to the design, development, and qualification of packaging systems that ensure product protection, patient safety, and compliance with global regulatory standards. This role offers hands-on experience across the product lifecycle—from early-phase clinical development through commercial launch. Key Responsibilities
Serve as a Packaging Development representative on cross-functional product development teams, supporting container closure system selection and development from Phase 1 through commercial transfer. Collaborate with internal stakeholders and external contract manufacturing organizations (CMOs) to coordinate clinical packaging operations and provide technical support, including on-site troubleshooting. Assist in the evaluation, characterization, and qualification of primary, secondary, and tertiary packaging components (e.g., vials, stoppers, syringes, blisters, bottles, caps, cartons, trays, shippers). Design, author, and execute packaging development protocols, test plans, and technical reports in accordance with internal procedures and regulatory expectations. Support packaging equipment and process qualifications (IQ/OQ/PQ) and participate in packaging line trials under supervision. Conduct hands-on testing and documentation activities in the packaging development laboratory, including sample preparation and data collection. Author and maintain packaging specifications, bills of materials (BOMs), and other technical documentation within document control systems. Support regulatory submissions by providing packaging-related documentation and data for INDs, NDAs, BLAs, and other filings. Participate in risk assessments (e.g., FMEA) related to packaging systems and processes. Assist in change control activities related to packaging components and specifications. Support sustainability initiatives by evaluating and recommending environmentally responsible packaging solutions. Maintain compliance with internal quality systems and participate in audits or inspections as needed. Travel to CMOs, suppliers, and other sites as needed to support packaging operations, qualifications, and issue resolution. Basic Qualifications
Bachelor’s OR Associate and 2+ years of relevant experience OR High School Diploma/GED and 3+ years of relevant experience Preferred Qualifications
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, or a related scientific discipline. Strong foundational knowledge of packaging principles, materials, and engineering practices. Excellent written and verbal communication skills, with the ability to produce clear, concise, and accurate technical documentation. Proficiency in Microsoft Office and familiarity with document management systems. Strong organizational skills and attention to detail. Familiarity with FDA regulations, current Good Manufacturing Practices (cGMP), and United States Pharmacopeia (USP) standards. Interest in and basic proficiency in Computer-Aided Design (CAD) tools. Familiarity with design controls and human factors engineering principles. Exposure to materials science, thermal testing, or transport simulation methods is beneficial. Experience with labeling development and serialization requirements is a plus. Basic understanding of ISO 11607, ICH guidelines, or EU MDR is helpful. Ability to work effectively in a team-oriented, fast-paced environment. Preferred Attributes
Eagerness to learn and grow within a regulated industry. Collaborative mindset with a proactive approach to problem-solving. Willingness to travel and engage with cross-functional teams and external partners. Compensation and Benefits
The salary range for this position is: $82,195.00 - $106,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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
For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity
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. For Current Gilead Employees And Contractors, please apply via the Internal Career Opportunities portal in Workday. Seniority level: Not Applicable Employment type: Full-time Job function: Engineering and Information Technology Industries: Biotechnology Research and Pharmaceutical Manufacturing
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