Engineering Manager-(EtO) Sterilization

Alleset•Dothan, AL

10h•Onsite

About The Position

The Engineering Manager – Ethylene Oxide Sterilization provides technical leadership for EO sterilization processes, cycle development, validation support, process improvement, and equipment reliability at ETO in Columbia, Alabama. The role serves as a technical resource across preconditioning, chamber processing, aeration, and related equipment and controls, and leads efforts to improve cycle consistency, throughput, capacity utilization, and operating efficiency while maintaining validated process requirements. The position develops and optimizes sterilization cycles in collaboration with Quality, customers, and technical resources; prepares and executes engineering studies; and supports equipment qualification, sterilization validation, requalification, and process performance assessments. It investigates cycle deviations and equipment issues, leads root cause analysis, supports corrective and preventive actions, and manages approved change control and associated technical documentation. The manager also supports equipment reliability, calibration and preventive maintenance strategies, capital projects, facility expansion, commissioning, and startup. The role collaborates with Environmental, Health and Safety on process risks and safe EO handling, provides technical support for customer inquiries, audits, and inspections within assigned approval authority, and trains, coaches, and mentors employees. Work takes place in office and controlled industrial sterilization environments, with occasional support outside normal business hours potentially required.

Requirements

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.
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.

Nice To Haves

Experience in contract sterilization or medical device manufacturing.
Familiarity with ISO 11135 and related sterilization quality requirements.
Experience with biological indicators, product and load families, aeration studies, and EO residual considerations.
Experience with statistical analysis, design of experiments, process capability studies, or Lean Six Sigma methods.
Experience with chamber controls, data acquisition systems, equipment commissioning, or capital expansion projects.

Responsibilities

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.
Develop and optimize sterilization cycles with Quality, customers, and technical resources, evaluating 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.
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.
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.
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.
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.