Job Description

We are looking for a Packaging Engineer I who will interface with vendors to develop alternate designs of packaging components and translate into actionable specs. Responsibilities Lead packaging development activities for clinical programs, ensuring alignment with product requirements, regulatory expectations, and global standards. Apply sound engineering principles and industry standards (e.g., USP, ISO, ASTM) to the design and qualification of container closure systems (CCS). Author and execute packaging studies, including protocols and reports for component qualification, shipping validation, and compatibility assessments. Conduct and support equipment and process qualification activities (IQ/OQ/PQ) for packaging lines and configurations at internal and external manufacturing sites. Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines. Investigate and resolve packaging-related deviations, non-conformances, and complaints in collaboration with Quality and Operations teams. Support regulatory submissions by authoring and reviewing relevant sections of INDs, NDAs, BLAs, and other global filings. Maintain and author SOPs related to packaging development and ensure alignment with broader organizational procedures. Collaborate with external partners including CMOs, suppliers, and test laboratories to ensure timely and compliant execution of packaging activities. Travel up to 25% may be required to support project execution at external sites. With guidance may participate on cross-functional project teams, to help meet complex project deliverables such as new product launches or start-up of new manufacturing/packaging sites. With guidance, performs fairly routine tasks to aid technical investigations and assessment of deviations, particularly as related to data generation/gathering and analysis. Prepares required engineering and manufacturing documentation, for revision and approval by manager/supervisor. Works on assigned projects through completion with limited direct supervision. Interfaces with production sites to improve/optimize current production processes. Basic Qualifications Master’s OR Bachelor’s and 2+ years of relevant experience OR Associate and 4+ years of relevant experience OR High School Diploma/GED and 5+ years of relevant experience Preferred Qualifications Good verbal, written, and interpersonal communication skills are required. Normally receives limited instructions on routine work and general instructions on new assignments. Works on problems of a routine to basic scope where analysis of data requires evaluation of identifiable factors. Specific education and experience requirements: BS or MS degree in a science field, preferably in an engineering field or a related technical discipline. #J-18808-Ljbffr Gilead Sciences, Inc.

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