
Associate Packaging Engineer
United States - California - Foster CityProcess/Product Development & OperationsRegularDescription de l'emploi
Associate Packaging Engineer
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Job Responsibilities
- Represent Packaging Development on multiple product development teams, delivering container closure solutions on schedule throughout development (e.g., Phase 1 through commercial transfer)
- Collaborate with contract manufacturing organizations (CMOs) to coordinate clinical packaging operations, provide technical support to resolve issues, perform on-site troubleshooting
- Perform characterization and qualification of packaging components and systems (e.g., bottles, caps, blisters, vials, seals, stoppers, syringes)
- Design, author, and execute packaging protocols and reports to support product development
- Under guidance, coordinate and perform equipment/process line trials and qualifications (IQ/OQ/PQ)
- Document and perform activities in package development lab
- Author packaging specifications and bills of materials
- Overnight travel may be required up to 25% of time
Knowledge, Experience and Skills
- B.S. degree in packaging engineering, mechanical engineering, or a related scientific field
- Entry-level position
- Strong technical knowledge of package development principles and packaging engineering operations is required
- Ability to write clear, concise, and error-free documents is required
- Strong verbal, written, and interpersonal communication skills are required
- Strong computer and organizational skills are required
- Familiarity with Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMP), and United States Pharmacopeia (USP) standards is desirable