2027 Future Talent Program - Packaging Component Engineer
PharmaRegulatory AffairsQuality Assurancegmpemacroraveinformaws
Job description
Job Description Responsible for supporting packaging and component engineering capabilities for the Wilson site focused on effective component life cycle management, related quality investigations, lines projects, and packaging continuous improvement projects. Responsible for process performance support and troubleshooting products packaged at our Wilson location and working closely with other site and above-site groups for the introduction of new products, network transfers and processes as well as external suppliers, packaging commercialization, and global support functions. This position will report to the Associate Director of Packaging Technical Operations (PTO Component Engineering) and will have frequent interaction with other business units at the site as well as external suppliers, packaging commercialization, and global support functions. The team will also support other engineering activities at the site as well as quality risk management. Primary Responsibilities · Author new and revise specifications for components with cross-functional team and align performance requirements to maintain consistent performance. · Work with component vendors to develop new/test components to support equipment qualifications, stability, distribution studies, and product launches for various global markets. · Assist with design transfer process from packaging commercialization team and partner with above site Packaging Technical Operations team to provide input to upcoming changes and strategic initiatives. · Act as Change Initiator/Project Manager for component related changes and SME for impact assessments/tasks on all site changes for assigned area. · Initiate/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 for weekend and off-shift work); Initiate/manage events in the supplier Incident Management System (IMS) for supplier investigations. · 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 introduction. · Facilitate machine trials and provide technical assessments for packaging component introduction and changes throughout 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 deviation recurrence; includes determination of event scope, impact assessments, root cause, identifying corrective/preventative actions, and remediation steps/final dispositions. · Directly supports regulatory inspections and audits; Provide engineering support to packaging operation assuring technical site readiness and regulatory agency observations. · Participate in Design Requirements Specifications, Design Reviews, Review of Purchase Specs and Functional Spec. · Participate on FATs and execution of IQ/OQ/PQ with focus on component interaction and packaging system integrity. · Support quality risk management assessments related to packaging operations and components. Education Minimum Requirements · B.S. degree in Packaging Science preferred or other Engineering degree to be considered with COOP, Internship or 6 months experience in packaging operations, pharmaceutical unit operations, or process design. Preferred Experience and Skills · Prior Co-Op/Intern experience with comprehensive background in packaging process and components · Experience working in GMP environment · 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.) FTP2027 FTJobs Required Skills: Applied Mathematics, Applied Mathematics, Cold Chain Management, Engineering Specifications, Engineering Standards, Engineering Support, Equipment Designing, Equipment Engineering, Legal Compliance, Life Cycle Planning, Maintenance Supervision, Manufacturing Quality Control, Manufacturing Scale-Up, Materials Science, Package Testing, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Operations, Packaging Processes, Packaging Science, Packaging Testing, Procedure Writing, Product Improvements, Product Packaging Design {+ 9 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $71,900.00 - $113,200.0
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