Safecor Health, LLC
  • 24-Nov-2017 to 31-Dec-2018 (EST)
  • Other
  • Columbus, OH, USA
  • Salary
  • Full Time

Medical, Dental, Vision, Short Term Disability, Life Insurance, PTO, EST, 401k


The Director of Engineering and Process Improvement will be responsible for directing various project work including optimization and validation of facilities, packaging design, project management, identification and validation of new manufacturing equipment, ERP transformation, and overall process improvement in all of the Company's businesses. Contribute to other projects, as assigned. Exposure to and completing assignments based on Pharma, Medical Device, FDA, DEA and cGMP requirements.

        Director of Engineering/Process Improvement Responsibiities:

  • Recommends process improvements related to packaging service and commercial service products, including lean manufacturing, automation and robotics.
  • Analyzes production metrics and results.
  • Documents and maintains change control plans including equipment validation- IQ/OQ/PQ development and execution
  • Develops bar codes, symbology, and labeling processes when appropriate
  • Performs Risk Assessments and FMEA
  • Supports manufacturing issues, CAPA's, SCARS and audits
  • Understands and applies ISO 11607-1 and 11135-1 for terminal sterilization and FDA CFR 820 and ISO 13485 for medical device packaging compliance
  • Responsible for design control for any drug/device combo products to the extent any new products are not accompanied by design control processes from contract manufacturing customers
  • Responsible for updating and writing Standard of Operating Procedures (SOPS) and related work instructions
  • Responsible for master validation plans for facilities and equipment
  • Fosters a high level of creativity and independence in the design and development of new or improved packaging processes, systems, prototypes and projects
  • Creates project plans and organizes resources to ensure project milestones and costs are met
  • Manages package development and improvement projects across the enterprise to meet Company and regulatory needs, including working with vendors on materials and designDirector of Engineering/Process Improvement - Knowledge, Skills and Experience:
  • Bachelor's degree in Industrial, Quality or Mechanical Engineering required
  • Experience in package and process engineering, structured problem solving, use of statistical tools, pharmaceuticals, medical devices and the packaging of sterilized products
  • Experience in design for manufacturing, FMEA, DOE and validations
  • Training and experience in Lean and Six Sigma, or equivalent
  • Working knowledge of ISO 13485, ISO 11607, ASTM D6198, and ASTN D4169
  • Proven leadership in project management and working across functional teams to accomplish project objectives
  • Health care experience preferred, particularly in packaging or manufacturing
  • Process and strong results orientation
  • Professional verbal communication skills including the ability to work well with all levels of internal management and staff
  • Effective written communication skills including the ability to draft and edit documents
  • Strong organizational skills
  • Proficiency in CAD software
  • Ability to prioritize workload and keep projects on task
  • Must be authorized to work in the United States

 

Safecor Health, LLC
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