Associate Director, Packaging Engineer

Role Summary

Associate Director, Packaging Engineer at Insmed, based in Bridgewater, NJ with a hybrid on-site/remote work setup. You will lead packaging development projects from concept to implementation, ensuring compliance with regulatory requirements, protecting product integrity, and enhancing user experience. You will oversee packaging development from initiation through clinical and commercial manufacture, managing timelines, budgets, and cross-functional collaboration with quality, finance, procurement, regulatory, engineering, operations, consultants, and outside vendors.

Responsibilities

• Lead packaging development projects utilizing materials related to pharmaceutical packaging (plastics, glass, films, fiberboard, corrugated)
• Execute projects encompassing primary through tertiary packaging development including labeling and combination product kits
• Generation/Review and approval of test plans and reports for packaging validation
• Creating and maintaining timelines
• Completion of qualification programs for new package designs and materials
• Implementation of cost-saving initiatives related to package designs and materials
• Initiate/Review of Change Controls, Deviations, and CAPAs related to packaging components
• Conduct hands-on evaluation of packaging for conformance to project and regulatory requirements
• Oversight responsibilities for commercial packaging sites and CMOs

Qualifications

• BS degree in Package Engineering, Mechanical Engineering or Engineering Sciences (Required)
• Minimum of 7 years of relevant experience in pharmaceutical or medical device packaging (Required)
• Preference for candidates with experience in pharmaceutical packaging areas (Preferred)
• Primary through tertiary packaging development for new product launch (Desired)
• Coordination and completion of qualification for new package designs and materials (Desired)
• Development of component specifications (Desired)
• Knowledge across different packaging materials / converting methods:
  • Corrugated containers
  • Folding cartons (solid fiberboard)
  • Plastic bottles/Glass vials
  • Flexible Packaging
  • Labeling
  • Patient Kits
  • Thermoformed Packaging
• Excellent project management skills (Required)
• Strong interpersonal skills and ability to work with cross-functional teams (Required)
• A self-motivated and proactive personality with ambition to “learn and deliver” in a fast-paced environment (Required)
• Experience with cost reduction initiatives and vendor management (Preferred)
• High competency in CAD software, Microsoft applications, and general computer usage (Required)
• Familiarity with cGMPs (Required)

Skills

• Project management
• Cross-functional collaboration
• Vendor management
• CAD and computer proficiency

Education

• BS degree in Package Engineering, Mechanical Engineering or Engineering Sciences

Additional Requirements

• Travel to vendor and manufacturing locations for support of packaging project activities (up to 20%)