Senior Pharmaceutical Packaging Engineer, Technical Operations

Position Summary

The Senior Pharmaceutical Packaging Engineer, Technical Operations is responsible for the design, development, qualification, implementation and lifecycle management of packaging systems for pharmaceutical combination products. The role will serve as the packaging subject matter expert (SME) to collaborate with the commercial packaging organization (CPO) and ensure that the pharmaceutical packaging meets product protection, global regulatory, manufacturing and distribution requirements, supporting programs from development through commercialization.

• Packaging Design and Development – Lead the development and finalization of packaging configurations, including primary packaging, labels, cartons, shippers and ancillary components. Oversee secondary packaging to facilitate patient adherence and meet Human Factors requirements. Drive innovation in sustainable materials without compromising product stability or sterile barrier integrity. Ensure configurations are commercially viable, manufacturable, cost‑effective and aligned with supply chain requirements. Develop, review and approve packaging specifications, component drawings, bills of materials and instructions.
• Packaging Technology Transfer and Implementation – Lead technology transfer activities from development through clinical and commercial manufacturing. Ensure successful transfer of packaging processes, specifications and operational requirements to external partners. Review and approve batch records, specifications, protocols and validation documents. Qualify and validate packaging lines and processes. Lead continuous‑improvement initiatives.
• Packaging Qualification and Validation – Design and execute packaging validation strategies, ensuring processes are capable, repeatable and compliant. Conduct Transportation Simulation Studies (ASTM D4169 or ISTA standards) to maintain product integrity during shipping. Support shipping validation and distribution qualification and conduct risk assessments covering design, process and distribution risks.
• Commercialization and Launch Readiness – Ensure packaging solutions support commercialization requirements, including labeling compliance, serialization and traceability. Support lifecycle‑management activities, including updates, improvements and change implementation.
• Serialization, Traceability and Distribution Support – Ensure compliance with serialization and traceability regulations (DSCSA and global standards). Support distribution through specialty pharmacy, wholesale and logistics networks. Manage cold‑chain packaging and monitoring for temperature‑sensitive products.
• Quality and Regulatory Compliance – Ensure all packaging activities comply with cGMP, FDA, EMA and other global regulatory requirements. Lead regulatory submissions related to packaging. Participate in audits, inspections, deviation investigations, root‑cause analysis, change control and CAPA activities.
• Documentation and Technical Review – Author, review and approve packaging documentation including specifications, drawings, batch records, validation protocols and transfer documents. Ensure completeness and regulatory compliance.

• M.S. or B.S. degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design or related technical field (advanced degree preferred).
• Minimum eight years of pharmaceutical, biotech or medical‑device packaging experience, including clinical and commercial operations.
• Direct experience supporting packaging technology transfer, commercialization, validation and qualification.
• Experience working with Commercial Packaging Organizations (CPOs).
• Strong knowledge of pharmaceutical packaging systems, cGMP, FDA, EMA and global regulations.
• Experience with serialization and traceability requirements (DSCSA preferred).
• Understanding of cold‑chain packaging and distribution.
• Experience managing late‑phase or commercial programs.
• Excellent communication, decision‑making, collaboration and attention‑to‑detail skills.
• Six Sigma or statistical knowledge is a plus.
• Ability to travel 10–20% domestically and internationally.

• Knowledge of primary packaging, labels, cartons and shippers.
• Understanding of regulatory requirements and documentation.
• Strong professional experience in the pharmaceutical industry, preferably in injectables.
• Ability to adapt to changes and implement new strategies.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.