Senior Specialist Packaging Component Engineer

Role: Senior Packaging Component Engineer supporting packaging and component engineering at a pharmaceutical manufacturing site. Objectives include managing component lifecycle, quality investigations, line projects, and process improvements, with a focus on supporting new product introductions, network transfers, and packaging process changes. Responsibilities: authoring specifications, collaborating with vendors on testing and qualification, managing design transfer processes, acting as Change Owner for site changes, troubleshooting line issues, providing technical support for standards and deviations, and supporting regulatory inspections and audits. Qualifications: B.S. or M.S. in engineering with 4–5+ years in packaging operations, pharmaceutical processes, or process design; GMP environment experience; project management skills; knowledge of problem-solving techniques like root cause analysis and Lean Six Sigma; technical writing proficiency; familiarity with medical device and combination product requirements. HighValue: pharmaceutical packaging, component lifecycle management, quality investigations, process validation (IQ/OQ/PQ), deviation management, GMP compliance, cross-unit collaboration, and 10% travel. WorkSetup: onsite with potential off-shift support.