Senior Engineer, Oral Solid Dose Packaging Development

Role: Senior Engineer specializing in Oral Solid Dose Packaging Development, leading technical aspects from early clinical phases through commercialization and lifecycle management. Responsibilities: oversee packaging material selection, container closure system development, and packaging validation; establish strategies, specifications, and controls according to regulatory and product needs; lead technical assessments, packaging qualification, and technology transfer; manage packaging artwork, regulatory content, and lifecycle changes; collaborate with cross-functional teams and external vendors on emerging materials and technologies. Requirements: Bachelor's degree in Packaging Science, Engineering, or related field with 4+ years of pharmaceutical packaging development experience; hands-on expertise with oral solid dose packaging, including bottles and blisters; knowledge of cGMP, FDA, ICH, USP, ASTM, ISO standards; experience supporting packaging across clinical and commercial phases, including regulatory submissions. Preferred: over 6 years of experience, leadership in packaging programs from early clinical to post-market, familiarity with sachet, flexible, and parenteral packaging, and special packaging considerations such as moisture-sensitive or patient-centered systems. HighValue: focus on oral solid dose products, lifecycle management, regulatory documentation, packaging validation, and cross-functional collaboration. WorkSetup: not specified; likely in a regulated lab/office environment with potential vendor interactions.