Principal Process Engineer - Aseptic Fill & Finish

Design Group

Base: $170k - $240k; bonus/equity: not specified; ...
20 years pharmaceutical process engineering experience
Expertise in aseptic filling and sterilization
Deep understanding of fda/ema regulatory guidelines
This role involves leading front-end design programming for formulation, sterilization, and aseptic processing while ensuring alignment with regulatory guidance

Job Summary

  • This role involves leading front-end design programming for formulation, sterilization, and aseptic processing while ensuring alignment with regulatory guidance.
  • The successful candidate will act as a recognized industry expert, contributing to business development through proposal writing and presenting at industry conferences.
  • Join a rapidly growing team of over 1500 professionals within a $3 billion diversified global supplier committed to building the future of manufacturing.

Matching Summary

This role involves leading front-end design programming for formulation, sterilization, and aseptic processing while ensuring alignment with regulatory guidance.

Salary

Base: $170K - $240K; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 20 years pharmaceutical process engineering experience
  • Expertise in aseptic filling and sterilization
  • Deep understanding of FDA/EMA regulatory guidelines
  • Experience with isolators and RABS technology
  • Ability to develop P&IDs and construction documents

Nice-to-have

  • Familiarity with 3D modeling software
  • Experience with computer-based hydraulic analysis
  • Published thought leadership in aseptic processing
  • Outgoing personality for client presentations
  • Willingness to travel for project installation

Key Requirements

  • Minimum 20 years of pharmaceutical and biologics experience
  • BS degree in Chemical, Mechanical, or Bio Engineering preferred
  • Front-end feasibility study experience required
  • Expertise in developing Master Batch Records and SOPs

Work Rights

Not specified

Tailored Resume

Cover Letter