Senior Specialist Packaging Component Engineer

Job Description

We have an exciting opportunity for a Senior Packaging Component Engineer at our Wilson site. This role is pivotal in supporting packaging and component engineering capabilities, focusing on effective component life cycle management, quality investigations, line projects, and continuous improvement initiatives. Join our team and contribute to the introduction of new products, network transfers, and processes, while collaborating with external suppliers and global support functions.

This position will report to the Associate Director of Packaging (Component Engineering) and will have frequent interaction with other business units at the site as well as external suppliers, packaging commercialization, device development and technology, and global support functions. The team will also support other engineering activities at the site as well as quality risk management.

Off-shift support may be required due to business critical needs.

• 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.

Required

• 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…