Process Engineer – Aseptic Filling

Job Title: Senior Validation Specialist, Aseptic Process Simulation (Media Fill)

Location: Columbus, OH (Relocation Bonus)

Position Summary

Seeking an APS (Aseptic Process Simulation) subject matter expert to lead media fill strategy and execution for sterile fill-finish operations (small-volume vial filling). This is a highly specialized, hands-on role focused specifically on designing, writing, and executing APS protocols—not general validation.

Key Responsibilities

• Own and execute aseptic process simulation (media fill) program
• Design robust APS protocols, including worst-case interventions (e.g., machine stops, aseptic manipulations)
• Lead end-to-end media fills (protocol writing, execution, analysis, reporting)
• Drive deviation investigations, root cause analysis, and revalidation
• Support process validation (PPQ/CPV) and contamination control strategies
• Ensure compliance with FDA and EU GMP Annex 1 requirements
• Partner cross-functionally with Manufacturing, QA, MS&T, and Microbiology
• Support audits and regulatory inspections

Required Experience

• 5+ years in sterile injectable manufacturing (pharma/biopharma)
• Direct experience writing and executing APS/media fills
• Strong knowledge of aseptic processing, contamination control, and risk-based validation
• Experience with small-volume vial filling (1,000–2,000 units/batch) preferred

Ideal Background

• Hands-on aseptic filling operator experience (strong plus)
• Experience in Validation, MS&T, Process Engineering, or Manufacturing
• Biologics or gene therapy manufacturing experience preferred
• Bachelor’s or Master’s degree preferred (Associate’s considered with strong hands-on experience; PhD not typical for this role)

Additional Notes

• Title flexibility (e.g., Validation vs. Process Engineering) to better match candidate backgrounds
• Fast-moving process with potential for immediate hire
• High-impact role supporting sterile manufacturing of advanced therapies