Process Owner, Aseptic Process Simulation

Genentech

Hillsboro, OR, US
Base: $114,000 - $212,000; bonus/equity: discretio...
Aseptic process simulation expertise
Sterile gmp environment experience
Process validation and contamination control
As Process Owner, you will lead the aseptic process simulation program ensuring robust, compliant, and harmonized execution at the Hillsboro site

Job Summary

  • As Process Owner, you will lead the aseptic process simulation program ensuring robust, compliant, and harmonized execution at the Hillsboro site.
  • This role offers significant impact on commercial production, site strategy, and global compliance with opportunities for industry-wide collaboration.
  • You will engage closely with Manufacturing, Quality Assurance, and Regulatory teams while preparing for inspections and driving continuous process optimization.

Matching Summary

As Process Owner, you will lead the aseptic process simulation program ensuring robust, compliant, and harmonized execution at the Hillsboro site.

Salary

Base: $114,000 - $212,000; Bonus/Equity: Discretionary annual bonus; Benefits: Provided including relocation

Skills & Requirements

Must-have

  • Aseptic process simulation expertise
  • Sterile GMP environment experience
  • Process validation and contamination control
  • Risk-based methodology application
  • Regulatory guideline compliance
  • Media Fill planning and execution
  • Cross-functional collaboration

Nice-to-have

  • Continuous improvement mindset
  • Lean principles knowledge
  • Digital tools affinity
  • Strong analytical and communication skills
  • Experience with global networks

Key Requirements

  • Bachelor's degree or equivalent in Engineering, Pharmacy, Microbiology or related field
  • Minimum 8+ years sterile GMP experience
  • Masters degree preferred
  • Familiarity with ISO 13408-1, PIC/S, FDA, EU GMP Annex 1
  • Experience in aseptic process simulation and validation
  • Experience in deviation management and root cause analysis

Work Rights

Not specified

Tailored Resume

Cover Letter