Senior Pharmaceutical Packaging Engineer, Technical Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Accountable for the design, development, qualification, implementation, and lifecycle management of packaging systems for pharmaceutical combination products.

• Act as the packaging subject matter expert (SME) and partner with the commercial packaging organization (CPO).

• Lead the creation and finalization of packaging designs, which include primary packaging, labels, cartons, shippers, and ancillary components.

• Supervise the development of user-focused secondary packaging that promotes patient adherence and complies with Human Factors (HF) requirements.

• Propel innovation in sustainable packaging materials while ensuring product stability and the integrity of sterile barriers are maintained.

• Confirm that packaging configurations are commercially viable, manufacturable, cost-effective, and aligned with supply chain and distribution needs.

• Create, review, and approve packaging specifications, component drawings, bills of materials, and packaging instructions.

• Lead packaging technology transfer initiatives from development through to clinical and commercial manufacturing.

• Ensure effective transfer of packaging processes, specifications, and operational needs to external partners.

• Spearhead packaging process optimization and continuous improvement efforts.

• Design and implement detailed Transportation Simulation Studies (in accordance with ASTM D4169 or ISTA standards) to maintain product integrity across global shipping routes.

• Author and defend Thermal Mapping studies and Lane Qualifications for global distribution centers.

⛳️ Requirements

• M.S. or B.S. degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or a related technical discipline is required.

• A minimum of 8 years of experience in pharmaceutical, biotech, or medical device packaging.

• Direct experience in supporting clinical and commercial packaging operations.

• Proven experience collaborating with CPOs.

• Experience in supporting packaging technology transfer and commercialization.

• Familiarity with packaging validation and qualification processes.

• Strong understanding of pharmaceutical packaging systems, including primary packaging, labels, cartons, and shippers.

• Comprehensive knowledge of cGMP and regulatory standards.

• Knowledge of FDA, EMA, and global packaging regulations.

• Experience in supporting serialization and traceability requirements (DSCSA preferred).

• Understanding of cold chain packaging and distribution methods.

• Experience in reviewing packaging batch records, specifications, and validation documents.

• Experience managing late-phase/commercial programs and post-launch lifecycle management.

🏝️ Benefits

• Premium health coverage.

• Financial, work-life, and well-being offerings for eligible employees and their dependents.

• Wellness and employee support programs.

• Life insurance.

• Disability coverage.

• Retirement plans with employer matching.

• Generous paid time off.