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Process Validation Engineer

3 months ago

Warwick, Rhode Island, United States Cynet Systems Full time
Job Description:

Responsibilities:
  • Support new product team and line extension activities including.
  • Concept development.
  • Project Plans/Schedules.
  • Design reviews and design for manufacturability.
  • Develop prototype packaging/tooling.
  • Plan and coordinate all activities to launch and commercialize new products and line extensions including.
  • Concept and development of packaging methods and processes.
  • Coordination of all new tooling and equipment.
  • Coordination of labeling.
  • Development and release of all new product and process documentation.
  • Creation of all relevant test protocols and technical reports.
  • Planning, ordering and coordination of all new component inventory.
  • Qualification and validation of all new components, equipment, processes and operations.
  • New product cost estimates for packaging.
  • Preparation of AFE(s).
  • Evaluation and recommendation of new materials.
  • Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including.
  • Development and management for packaging requirements of the transfer plan.
  • Development and release of all packaging documentation.
  • Creation of all relevant test protocols and technical reports.
  • Provide packaging engineering support to manufacturing including the following.
  • ssessment and development of action plans to overcome packaging related manufacturing issues.
  • Support of cost improvement programs and manufacturing improvement plans related to product packaging.
  • To plan, organize, and coordinate all Packaging Engineering and labeling-related activities to support.
  • Development and commercialization of new products and line extensions.
  • Manufacturing maintenance-of-business activities.
  • Cost Improvement Programs.
  • Testing and labeling activities to support ever-changing regulatory and industry requirements.
  • Investigation, evaluation, and implementation of new packaging concepts, materials and systems.
  • Technical initiatives, CAPA resolutions, compliance projects.
Qualifications, Knowledge, and Skills Required:
  • Senior Packaging Engineer: B.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of five years in packaging engineering and design, or M.S. degree in Packaging Engineering/Packaging Science, Life Sciences or other Engineering discipline required, with a minimum of four years relevant experience.
  • Experience in the medical device or pharmaceutical industries preferred.
  • bility to handle a variety of assignments at the same time.
  • High level of written and verbal communications skills.
  • Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.
  • bility to conceptualize ideas, motivate and focus individuals and teams and drive projects through to completion on time and on budget.
  • Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.
  • Working knowledge of package test methods, process validation, bar coding and international standards.
  • Some travel required.