Principal Process Engineer – Api + Osd

BW Forsyth PartnersT LLC

Base: $170k - $240k; bonus/equity: not specified; ...
20 years pharmaceutical process engineering experience
Api and osd process development expertise
Fda and ema regulatory compliance knowledge
The Principal Process Engineer will lead front-end design programming for API and OSD processes including site surveys and economic analysis

Job Summary

  • The Principal Process Engineer will lead front-end design programming for API and OSD processes including site surveys and economic analysis.
  • This role requires deep expertise in FDA/EMA guidelines such as USP <1116> and Annex 1 to ensure cGMP compliance.
  • Candidates must have a minimum of 20 years of pharmaceutical and biologics process system engineering experience to succeed in this position.

Matching Summary

The Principal Process Engineer will lead front-end design programming for API and OSD processes including site surveys and economic analysis.

Salary

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

Skills & Requirements

Must-have

  • 20 years pharmaceutical process engineering experience
  • API and OSD process development expertise
  • FDA and EMA regulatory compliance knowledge
  • Front-end feasibility study experience
  • Sterilization and aseptic filling expertise

Nice-to-have

  • Experience presenting at industry conferences
  • Familiarity with 3D modeling software
  • Computer-based hydraulic analysis skills
  • Process simulation software proficiency
  • Outgoing personality for client engagement

Key Requirements

  • Minimum 20 years of pharmaceutical process engineering experience
  • BS degree in Chemical, Mechanical or Bio Engineering preferred
  • Expertise in sterilization, aseptic filling, and sealing operations

Work Rights

Not specified

Tailored Resume

Cover Letter