Packaging Engineer III

Key Responsibilities

Commercial Packaging & External Manufacturing Support

• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of deviations, complaints, and investigations related to packaging, labeling, and logistics.
• Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
• Review deviations and CAPAs from external packaging site.
• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.

Technology Transfer & Validation

• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for oral solid dose products, parenteral products, biologics and combination products.
• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for oral solid dose products and parenteral products across global manufacturing networks.

Cross-Functional Partnership & Supply Continuity

• Partner closely with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
• Represent Packaging & Labeling on CMC teams, supporting lifecycle management activities for Gilead products.
• Support department leadership with resource planning and financial reporting activities.

Packaging Development & Documentation

• Review and approve specifications for primary, secondary, and tertiary packaging components used for commercial products.
• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.
• Initiate change controls, deviations and CAPAs in Gilead Quality Management system when required.

Compliance & Regulatory Oversight

• Maintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.
• Support regulatory submissions, regulatory agency inspections, and quality audits related to packaging and labeling activities, as needed.

Basic Qualifications

Bachelor's degree in Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field with minimum of 5 years of relevant industry experience, OR Master's degree in a related field with minimum of 3 years of relevant industry experience.

Knowledge, Experience And Skills

• Experience performing shipping qualifications and transportation studies including protocol authoring, sample preparation and report authoring.
• Experience creating material specifications (primary, secondary and tertiary packaging materials and components), Bill of Materials, packaging instructions, and Standard Operating Procedures.
• Experience with package development for various pharmaceutical products such as oral solid dose and parenteral products (small molecules or biologics) is a plus.
• Experience working with packaging sites and external contract packaging organizations to support routine production.
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Understanding of cGMPs, pharmaceutical manufacturing principles, and global packaging standards.
• Familiarity with applicable industry standards and test methods (e.g., USP, ISO, ASTM).
• Knowledge of distribution and cold chain shipping requirements for oral solid dose and parenteral products is a plus.
• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD) is a plus.
• Strong organizational and time-management skills, with the ability to manage multiple assignments and meet project timelines.
• Good verbal, written, and interpersonal communication skills are required.
• Overnight travel may be required up to 20% of the time.