Package Engineering Senior Manager

Vertex Pharmaceuticals Incorporated

Boston, Massachusetts, United States
Base: $138,400 - $207,600; bonus/equity: eligible ...
Hybrid
Packaging design and specification management
Container closure integrity (cci) testing per usp <1207>
Cad 3d modeling with solidworks
This role involves representing the department on cross-functional CMC sub-teams to ensure effective relationships with key suppliers and stakeholders

Job Summary

  • This role involves representing the department on cross-functional CMC sub-teams to ensure effective relationships with key suppliers and stakeholders.
  • The position requires leading technical transfer, process validation activities, and authoring packaging qualification documents in alignment with regulatory requirements.
  • Vertex offers a comprehensive total rewards package including medical benefits, generous paid time off, educational assistance, and potential annual bonuses and equity awards.

Matching Summary

This role involves representing the department on cross-functional CMC sub-teams to ensure effective relationships with key suppliers and stakeholders.

Salary

Base: $138,400 - $207,600; Bonus/Equity: Eligible for annual bonus and equity awards; Benefits: Medical, dental, vision, PTO, 401(k), student loan repayment

Skills & Requirements

Must-have

  • Packaging design and specification management
  • Container Closure Integrity (CCI) testing per USP <1207>
  • CAD 3D modeling with SolidWorks
  • Validation processes IQ OQ PQ PV
  • Risk analysis using d.F.M.E.A. u.F.M.E.A p.F.M.E.A
  • cGMPs and ISO 13485/14971 compliance
  • Contract Manufacturing Organization (CMO) management

Nice-to-have

  • Experience with Cell & Gene therapies packaging
  • Statistical principles and process capability analysis
  • Cross-functional stakeholder collaboration skills
  • Root Cause Analysis expertise
  • First-generation learnings application

Key Requirements

  • Bachelor's degree in Packaging, Mechanical, Chemical, or Material Engineering
  • 96 years of experience in Package Engineering Senior Manager related occupation
  • In-depth experience supporting packaging from research through commercial launch
  • Advanced knowledge of cGMPs and regulatory considerations
  • Thorough understanding of Design Control and risk management tools

Work Rights

Not specified

Tailored Resume

Cover Letter