Senior Pharmaceutical Packaging Engineer, Technical Operations
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Job Description
Senior Pharmaceutical Packaging Engineer at Travere Therapeutics designing and managing packaging systems for pharmaceutical combination products. Collaborating cross-functionally to ensure compliance with global standards.
Responsibilities:
- Responsible for the design, development, qualification, implementation and lifecycle management of packaging systems for pharmaceutical combination products
- Serve as the packaging subject matter expert (SME) and collaborate with commercial packaging organization (CPO)
- Lead the development and finalization of packaging configurations, including primary packaging, labels, cartons, shippers, and ancillary components
- Oversee the development of user-centric secondary packaging that facilitates patient adherence and meets Human Factors (HF) requirements
- Drive innovation in sustainable packaging materials without compromising product stability or sterile barrier integrity
- Ensure packaging configurations are commercially feasible, manufacturable, cost effective, and aligned with supply chain and distribution requirements
- Develop, review, and approve packaging specifications, component drawings, bills of materials, and packaging instructions
- Lead packaging technology transfer activities from development through clinical and commercial manufacturing
- Ensure successful transfer of packaging processes, specifications, and operational requirements to external partners
- Lead packaging process optimization and continuous improvement initiatives
- Design and execute comprehensive Transportation Simulation Studies (per ASTM D4169 or ISTA standards) to ensure product integrity across global shipping lanes
- Author and defend Thermal Mapping studies and Lane Qualifications for global distribution hubs
Requirements:
- M.S. or B.S. degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or related technical field required
- Minimum of 8 years of pharmaceutical, biotech, or medical device packaging experience
- Direct experience supporting clinical and commercial packaging operations
- Demonstrated experience working with CPOs
- Experience supporting packaging technology transfer and commercialization
- Experience supporting packaging validation and qualification
- Strong knowledge of pharmaceutical packaging systems, including primary packaging, labels, cartons, and shippers
- Thorough understanding of cGMP and regulatory requirements
- Knowledge of FDA, EMA, and global packaging regulations
- Experience supporting serialization and traceability requirements (DSCSA preferred)
- Understanding of cold chain packaging and distribution
- Experience reviewing packaging batch records, specifications, and validation documentation
- Experience in managing late phase / commercial programs and post-launch lifecycle management
Benefits:
- premium health
- financial, work-life and well-being offerings for eligible employees and dependents
- wellness and employee support programs
- life insurance
- disability
- retirement plans with employer match
- generous paid time off
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