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Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Budget Managementunmatched
Calendar Managementunmatched
Coding Standardsunmatched
Communication Skillsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cost Controlunmatched
Cost Estimatesunmatched
Documentationunmatched
FDA Requirementsunmatched
ISO (International Organization for Standardization)unmatched
Machine Toolunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Designunmatched
Medical Disposablesunmatched
Medical Equipmentunmatched
Operations Processesunmatched
Presentation/Verbal Skillsunmatched
Process Validationunmatched
Product Costingunmatched
Product Developmentunmatched
Product Documentationunmatched
Product Packagingunmatched
Product Planningunmatched
Product Supportunmatched
Product/Service Launchunmatched
Project Planningunmatched
Project Scheduleunmatched
Prototypingunmatched
Quality Assurance Methodologyunmatched
Regulationsunmatched
Technical Leadershipunmatched
Test Plan/Scheduleunmatched
Time Managementunmatched
Willing to Travelunmatched
Writing Skillsunmatched
Description
Senior Packaging Engineer
Location: Warwick, Rhode Island
Compensation:
Base Salary: USD 150,000 to $165,000
Full-time position with full benefits
Relocation assistance available for the ideal candidate
Visa sponsorship available
Summary/Purpose of Position: We are seeking a dedicated Senior Packaging Engineer to join our team. The successful candidate will plan, organize, and coordinate all packaging engineering and labeling-related activities to support the development and commercialization of new products and line extensions. This role includes ensuring compliance with ever-changing regulatory and industry requirements, and implementing new packaging concepts, materials, and systems.
Essential Duties and Position Responsibilities:
Support New Product Team and Line Extension Activities:
Concept development
Project plans and schedules
Design reviews and design for manufacturability
Develop prototype packaging and tooling
Launch and Commercialize New Products and Line Extensions:
Concept and development of packaging methods and processes
Coordination of new tooling and equipment
Coordination of labeling
Development and release of new product and process documentation
Creation of test protocols and technical reports
Planning, ordering, and coordination of new component inventory
Qualification and validation of new components, equipment, processes, and operations
New product cost estimates for packaging
Preparation of AFEs
Transfer New Products and Line Extensions to Manufacturing:
Development and management for packaging requirements of the transfer plan
Development and release of packaging documentation
Creation of test protocols and technical reports
Provide Packaging Engineering Support to Manufacturing:
Assess and develop action plans to overcome packaging-related manufacturing issues
Support cost improvement programs and manufacturing improvement plans related to product packaging
Provide technical leadership for technical initiatives, CAPA resolutions, and compliance projects
Qualifications, Knowledge, and Skills Required:
Educational Requirements:
B.S. degree in Packaging Engineering/Packaging Science, Life Sciences, or other Engineering field with a minimum of five years in packaging engineering and design
M.S. degree in Packaging Engineering/Packaging Science, Life Sciences, or other Engineering discipline with a minimum of four years of relevant experience
Experience and Skills:
Experience in the medical device or pharmaceutical industries preferred
Ability to handle a variety of assignments simultaneously
Knowledge and experience with ISO 11607-1 and 11607-2
High level of written and verbal communication skills
Knowledge of FDA requirements for sterile, non-sterile, disposable, and reusable devices
Ability to conceptualize ideas, motivate and focus individuals and teams, and drive projects to completion on time and on budget
Broad knowledge of materials used in primary and secondary packaging, packaging methods, and equipment
Working knowledge of package test methods, process validation, bar coding, and international standards