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Senior Engineer, Packaging Development

Exela Pharma Sciences LLC

Exela Pharma Sciences LLC

lenoir, nc, usa
Posted 6+ months ago

Position Summary:

The Senior Packaging Engineer supports the Quality and Regulatory Systems within the Engineering Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals in design and development of labeling and packaging materials and components.

Job Responsibilities:

  • Design and development of finished drug product labeling and packaging materials and components
  • Initiate Change Controls to document generation and approval of Raw Material Supporting Documents and Specifications for new and revised labeling and packaging components
  • Assist with raw material sourcing and procurement of labeling and packaging
  • Communicate with vendors on proofing and purchase order fulfillment
  • Serve as back-up project management representative for all finished product packaging
  • Collaborate with partners, regulatory, marketing and FDA to create / approve packaging
  • Source vendors to produce approved cartoning and labeling
  • Prepare and conduct packaging tests to ensure durability, efficiency, and functionality
  • Perform other duties as assigned

Required Skills:

  • Proficiency with Microsoft Office Applications
  • Familiarity with aseptic processing and sterile manufacturing highly desired
  • Must be able to read and write English, perform mathematical calculations, follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors
  • Must be able to manage projects and schedules, meeting milestones and timelines
  • Must be able to interact with others in a diplomatic and assertive manner while maintaining a teamwork attitude
  • Must be able to sit or stand for extended periods of time, must be able to climb stairs, must be able to lift and carry 35 lbs., must be able to walk while carrying items, and must be able to see very small print and tiny graduations

Education and Experience Requirements:

  • Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Material Science, or a related field. Equivalent combination of education and experience will be considered.
  • Five (5) years + of experience in packaging engineering, preferably in relevant industry, e.g., consumer goods, manufacturing, pharmaceuticals
  • Strong understanding of packaging materials, including plastics, paperboard, metals, and sustainable alternatives.
  • Knowledge of relevant regulatory and safety standards (e.g., ISTA, ASTM, ISO).
  • Excellent project management skills with a proven ability to manage multiple projects simultaneously.
  • Strong analytical, problem-solving, and organizational skills.
  • Excellent verbal and written communication skills, with an ability to clearly convey technical information to non-technical stakeholders.