Engineering Manager-(EtO) Sterilization

• Purpose:

• The purpose of this document is to define the responsibilities and qualifications of the Engineering Manager – Ethylene Oxide Sterilization at ETO in Columbia, Alabama. This position provides technical leadership for EO sterilization processes, cycle development, validation support, process improvement, and equipment reliability.

• Equipment:

• EO sterilization chambers, preconditioning and aeration systems, process monitoring and control systems, instrumentation, and related engineering tools and software.

• Responsibilities:

Process Engineering and Optimization:

• Serve as a technical resource for EO sterilization, including preconditioning, chamber processing, aeration, and related equipment and controls.
• Lead improvements in cycle consistency, throughput, capacity utilization, and operating efficiency while maintaining validated process requirements.
• Monitor and trend temperature, humidity, pressure, EO delivery or concentration, exposure time, and aeration performance to identify variation and recommend improvements.

Cycle Development and Validation:

• Develop and optimize sterilization cycles with Quality, customers, and technical resources; evaluate product and load configurations, process parameters, and acceptance criteria.
• Prepare and execute engineering studies and support equipment qualification, sterilization validation, requalification, and process performance assessments.
• Prepare protocols, analyze study results, and write technical reports in accordance with approved procedures.

Troubleshooting and Corrective Action:

• Investigate cycle deviations, process interruptions, and equipment performance issues; lead root cause analysis and support corrective and preventive actions.
• Partner with Operations, Quality, Maintenance, and equipment suppliers to troubleshoot instrumentation, sensors, vacuum systems, controls, and related equipment.

Change Control and Technical Documentation:

• Evaluate proposed changes to equipment, software, process parameters, load configurations, and procedures through approved change control, including assessment of validation impact.
• Prepare and maintain process specifications, engineering documentation, standard operating procedures, and technical training materials.

Equipment Reliability and Capital Projects:

• Work with Maintenance to improve equipment reliability and support calibration and preventive maintenance strategies for critical process equipment.
• Support capital projects and facility expansion through capacity analysis, equipment specifications, technical evaluations, installation support, commissioning, and startup.
• Manage assigned engineering projects, schedules, and technical deliverables.

Safety and Technical Support:

• Work with Environmental, Health and Safety on process risk assessments, safe operating practices, and engineering improvements related to EO handling, exposure prevention, and emissions control.
• Provide technical support for customer inquiries, audits, and inspections within assigned approval authority.
• Train and coach employees on process requirements and troubleshooting; provide technical direction and mentoring.
• Perform other related duties as assigned.

Qualifications/ Education:

• Bachelor’s degree in chemical, mechanical, biomedical, industrial, or a related engineering discipline.
• Experience analyzing process data, investigating deviations, identifying root causes, and implementing sustainable improvements.
• Five or more years of relevant process engineering experience, cycle development, validation, or technical process support. Direct experience with EO sterilization processes is required.
• Experience analyzing process data, investigating deviations, identifying root causes, and implementing sustainable improvements.
• Ability to interpret process flow diagrams, piping and instrumentation diagrams, equipment specifications, and technical reports.
• Strong project management, technical writing, communication, and cross functional collaboration skills; ability to manage priorities and work independently.
• Experience in contract sterilization or medical device manufacturing and familiarity with ISO 11135 and related sterilization quality requirements preferred.
• Experience with biological indicators, product and load families, 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.

Physical Demands:

• Ability to work in office and industrial sterilization environments, including periods of sitting, standing, and walking.
• Ability to access equipment areas and climb stairs or platforms as required.
• Ability to use computers, engineering tools, and related equipment.
• Ability to bend, stoop, kneel, or crouch as needed to inspect equipment and processes.
• Ability to review process data, instrumentation displays, drawings, and technical documents.
• Ability to use required personal protective equipment and follow site access and safety requirements.
• Essential functions may be performed with reasonable accommodation.

Work environment:

• Work is performed in office and controlled industrial sterilization environments and requires adherence to site safety procedures and personal protective equipment requirements.
• Occasional support outside normal business hours may be required for process issues, validation activities, or equipment startup.