EO Sterilization Engineering Lead

Alleset Inc; Dothan (AL); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Alleset Inc. is seeking an Engineering Manager for Ethylene Oxide (EO) Sterilization in the Dothan/Columbia area of Alabama.

You will provide technical leadership for EO sterilization processes, cycle development, validation support, and equipment reliability, while driving process improvements and quality compliance. Responsibilities include leading cycle development, validation execution, troubleshooting, documentation, and collaboration with Operations, Quality, and Maintenance to meet safety

Qualifikationen

• Bachelor’s degree in chemical, mechanical, biomedical, industrial, or a related engineering discipline.
• Five or more years of relevant process engineering experience, cycle development, validation, or technical process support; EO sterilization experience required.
• Experience analyzing process data, investigating deviations, identifying root causes, and implementing sustainable improvements.
• Strong project management, technical writing, communication, and cross-functional collaboration skills; ability to manage priorities and work independently.
• Experience with ISO 11135 and related sterilization quality requirements preferred.
• Experience with biological indicators, aeration studies, and EO residual considerations preferred.
• Experience with statistical analysis, design of experiments, process capability studies, or Lean Six Sigma methods preferred.
• Experience with chamber controls, data acquisition systems, equipment commissioning, or capital expansion projects preferred.

Aufgaben

• Provide EO sterilization process leadership and optimize cycles.
• Develop and validate sterilization cycles with cross-functional teams.
• Investigate deviations and lead root cause analysis.
• Support change control and maintain process documentation.
• Improve equipment reliability and support capital projects.
• Provide safety and technical support, training, and mentoring.

Kenntnisse

Process data analysis

Root cause analysis

Project management

Technical writing

Cross-functional collaboration

Quality systems

Statistical analysis

Lean Six Sigma

EO sterilization experience

Chamber controls

Data acquisition systems

P&ID interpretation

ISO 11135 familiarity

Ausbildung

Bachelor’s degree in chemical, mechanical, biomedical, industrial, or related engineering

Tools

Data acquisition systems

P&ID interpretation

ISO 11135 familiarity

Jobbeschreibung

Alleset Inc. is seeking an Engineering Manager for Ethylene Oxide (EO) Sterilization in the Dothan/Columbia area of Alabama.

You will provide technical leadership for EO sterilization processes, cycle development, validation support, and equipment reliability, while driving process improvements and quality compliance. Responsibilities include leading cycle development, validation execution, troubleshooting, documentation, and collaboration with Operations, Quality, and Maintenance to meet safety