Senior Specialist Packaging Component Engineer

Responsibilities

• Author new and revise specifications for components with cross-functional teams to maintain consistent performance.
• Work with component vendors to develop and test components to support equipment qualifications, stability, distribution studies, and product launches for various global markets.
• Assist with design transfer processes from packaging commercialization and device development teams, partnering with the Packaging Technical Operations team for upcoming changes and strategic initiatives.
• Act as Change Owner/Project Manager for component-related changes and SME for impact assessments/tasks on all site changes for assigned areas.
• Initiate and maintain workflows in GLAMS (Global Artwork Management System) for printed component structural drawings for usage by Print Coordinators and global markets in product artwork development.
• Troubleshoot line issues potentially related to component performance, including potential weekend and off-shift work; initiate and manage events in the supplier Incident Management System (IMS) for supplier investigations.
• Provide technical support to set and improve run standards based on component capability and variability.
• Partner with Procurement and Supplier Management teams for supplier performance monitoring, technical assessments, and new vendor introductions.
• Facilitate machine trials and provide technical assessments for packaging component introduction and changes throughout the product lifecycle.
• Provide technical SME support for component-related deviations and customer field complaints.
• Author quality event investigations for site component-related deviations to prevent recurrence, including determination of event scope, impact assessments, root cause analysis, identifying corrective/preventative actions, and remediation steps/final dispositions.
• Support regulatory inspections and audits, providing engineering support to packaging operations to ensure technical site readiness and address regulatory agency observations.
• Participate in Design Requirements Specifications, Design Reviews, Review of Purchase Specs, and Functional Specs.
• Participate in FATs and execution of IQ/OQ/PQ with a focus on component interaction and packaging system integrity.
• Support quality risk management assessments related to packaging operations and components.

• Bachelor of Science (B.S.) degree in engineering or equivalent and a minimum of five (5) years of experience in packaging operations, pharmaceutical unit operations, or process design OR Master of Science (M.S.) degree in engineering or equivalent and a minimum of four (4) years of experience in packaging operations, pharmaceutical unit operations, or process design.
• Comprehensive background in packaging process and components.
• Experience working in a GMP environment.
• Project management skills and experience implementing projects.
• Effective analytical and decision-making ability.
• Knowledge of formal problem-solving techniques such as root cause analysis and/or Lean Six Sigma.
• Technical writing and document review experience (deviations, change requests, standard operating procedures, protocols, etc.).
• Knowledge of Medical Device and Combination Product requirements, including design control, verification, and validation.

• Change Control Processes
• Change Control Processes
• Coaching Managers
• Competency Management
• Design Inputs
• Detail-Oriented
• Deviation Management
• Driving Continuous Improvement
• Engineering Specifications
• Engineering Standards
• Engineering Support
• Equipment Designing
• Equipment Engineering
• Innovation
• Life Cycle Planning
• Manufacturing Process Improvements
• Materials Science
• Package Testing
• Packaging Engineering
• Packaging Equipment
• Packaging Innovation
• Packaging Operations
• Packaging Processes
• Procedure…