Process Owner, Aseptic Process Simulation

As Process Owner, Aseptic Process Simulation, you will own, develop, maintain & deploy the overarching strategy for the execution, control, and continuous improvement of aseptic process simulation (Media Fill) program at the Hillsboro Technical Operations site.

Requirements

• Bachelor's degree or equivalent in Engineering, Pharmacy, Microbiology, Natural/Engineering Sciences, or a comparable technical qualification
• 8+ years experience in a sterile GMP environment
• Extensive experience and in-depth expertise in aseptic process simulation (Media Fill), process validation, contamination control, and risk analysis
• Familiarity with regulatory guidelines (ISO 13408-1, PIC/S, FDA, EU GMP Annex 1)
• Strong analytical skills, structured approach, and attention to detail in evaluation and documentation
• Excellent communication skills and experience working with broad, international networks
• Experience in interdisciplinary collaboration: Quality Assurance, Manufacturing, MSAT/Engineering, Regulatory

Benefits

• Relocation benefits
• Discretionary annual bonus
• Benefits detailed at the link provided below