Principal Process Engineer - Aseptic Fill & Finish

BW Forsyth PartnersT LLC

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

Job Summary

  • The role involves leading front-end design programming for formulation, sterilization, and aseptic processing while ensuring regulatory alignment.
  • Candidates must possess deep expertise in cGMP, FDA/EMA guidelines, and contamination control strategies for sterile drug products.
  • This position offers a path to becoming a world-class professional consultant within a rapidly growing team of over 1500 professionals.

Matching Summary

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

Salary

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

Skills & Requirements

Must-have

  • 20 years pharmaceutical process engineering experience
  • Expertise in sterilization and aseptic filling operations
  • Deep understanding of FDA/EMA regulatory guidelines
  • Experience with isolators, RABS, and VHP decontamination
  • Ability to develop P&IDs and equipment selection strategies

Nice-to-have

  • Familiarity with 3D modeling and hydraulic analysis software
  • Experience presenting at industry conferences
  • Background in emerging aseptic technologies
  • Strong business development and proposal writing skills

Key Requirements

  • Minimum 20 years of pharmaceutical and biologics process system engineering/design experience
  • BS degree in Chemical, Mechanical or Bio Engineering preferred
  • Proven track record in proposal generation and technical business development

Work Rights

Not specified

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