Sr Packaging Engineer II

Arbeitsbeschreibung

This position is in the Gilead External Manufacturing group, which is part of Gilead Manufacturing Operations organization. This role is in the Gilead Foster City location.

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.
• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.

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.
• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for parenteral finished goods, including small molecules, biologics, and combination products.

Technology Transfer & Validation

• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for parenteral products across global manufacturing networks.

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, inspections, and responses 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 at least 8 years of relevant industry experience,

OR

• Master’s degree in a related field with at least 6 years of relevant industry experience.

Knowledge, Experience And Skills

• Strong knowledge of cGMPs, pharmaceutical manufacturing principles, and global packaging standards.
• Technical proficiency, independent thinking, teamwork and collaboration, including driving continuous improvement.
• Demonstrated experience with secondary and tertiary packaging for parenteral products (small molecules and biologics).
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Experience with leading investigations and identifying appropriate CAPAs to prevent recurrence
• Proven experience working with and managing external contract packaging organizations.
• Proven experience leading complex, cross-functional projects across multiple regions and time zones. Proficient at using project management tools to develop detailed timelines. Identify risks and critical path items on the project timeline.
• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD) (preferred).
• Knowledge of distribution and cold chain shipping requirements for parenteral products; experience with shipping qualifications and transportation studies.
• Financial acumen related to budgeting, forecasting, and cost optimization.
• Working knowledge of statistical methods and software to support packaging process optimization and troubleshooting.