Sr. Process Engineer

Sterigenics; Oak Brook (IL); On-site; USD 92,000 - 149,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid holidays and vacation

Parental leave

Education assistance

Employee Assistance Program (EAP)

Job summary

Sterigenics in the United States is seeking a Sr. Process Engineer to analyze sterilization processes, identify inefficiencies, and drive improvements across multiple sites. The role focuses on EO technology, working with EHSS to ensure compliance with PSM and safety standards.

The engineer will lead cross-functional initiatives, develop new process designs, and support P&IDs for large projects, while applying RCA and Six Sigma tools to achieve robust, scalable processes. Travel is expected ~25%.

Qualifications

• B.S. in Engineering or related field or 10+ years related experience.
• Experience in both field and office environment.
• Knowledge of RCA and Lean Six Sigma tools.
• Excellent written and verbal communication skills.
• Travel will average 25%.

Responsibilities

• Analyze process data to identify inefficiencies in the sterilization process and implement improvements.
• Lead development and documentation of new sterilization processes.
• Update drawings and diagrams to comply with PSM program; validate with EHSS.
• Support project managers with P&ID for large-scale projects.
• Conduct root cause investigations using RCA tools and implement corrective actions.
• Develop and optimize SOPs and process-related technical standards.
• Collaborate on facility enhancement designs and commissioning; field verifications.
• Coordinate drawing updates from field-verified redlines; review vendor CAD revisions.

Skills

RCA tools

Lean Six Sigma

Process optimization

Cross-functional leadership

Technical communication

Education

B.S. in Engineering or related field

Job description

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Sr. Process Engineer

The Process Engineer analyzes process data to identify inefficiencies in the sterilization process and implements appropriate improvements. The Engineer also leads development and documentation of new sterilization processes. In collaboration with EHSS, the Engineer field verifies, updates, revises, and modifies process and plant drawings and diagrams to comply with Sterigenics PSM program. This position will primarily support the EO technology.

Duties And Responsibilities

• Perform all responsibilities in a safe manner. Follow Sterigenics Health and Safety procedures and requirements
• Lead cross-functional process improvement initiatives, applying advanced statistical analysis and simulation tools to optimize performance
• Designs robust processes that meet quality, safety, and regulatory standards, with scalability across multiple sites or systems
• Support Project Managers with development of new process designs, process flows, and Piping and Instrumentation diagrams (P&ID) for large scale projects
• Conduct root cause investigations for complex process failures utilizing recognized RCA tools (e.g. 5-Why, Fishbone diagrams, etc.) and implement sustainable corrective actions
• Develop and optimize SOPs and process-related technical standards
• Support General Facility Enhancement designs and commissioning; perform field inspections and verifications as needed
• Update and maintain repository for facility installed equipment summary files
• Work in close collaboration with Environmental, Health, and Safety to ensure process safety information is compliant with Process Safety Management (PSM) procedures and requirements
• Lead a committee to develop and document best practices for sterilization processes
• Coordinate drawing updates resulting from field-verified redlines
• Review, verify, and update existing controls drawings to the latest vendor revisions

Equipment Activities

• Perform site visits to assist in troubleshooting process related deviations
• Analyze process data and utilize RCA tools to identify & implement process and equipment improvements
• Ensure Process Safety Management equipment components are labeled or tagged to reflect current CAD drawing piping and instrumentation numbers/identification (P&IDs)
• Assist in providing equipment details and specifications for entries in maintenance management (CMMS) system files.
• Assist with special projects as directed

Education, Experience & Skill Required

• B.S. in an Engineering related field or 10+ years related experience
• Competent working in both field and office environment
• Working knowledge of Root Cause Analysis (RCA) and Lean Six Sigma tools
• Excellent written and verbal communication skills
• Strong computer skills
• OSHA Process Safety Management knowledge a plus
• Travel will average 25%

Pay And Benefits

Salary Range: 92,000 - 149,000 per year, depending on experience.

Sotera Health Offers a Competitive Benefits Package That Includes

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
• Employee Assistance Program (EAP)

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

VEVRAA Federal Contractor

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.