Job Description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Ethylene Oxide (EO) Analyst III provides Customer turnkey services in the areas of process validations, requalification’s, product adoptions, validation cost, laboratory coordination, and compliance documentation; maintaining approximately 11-15 Customer validations at any given time. This includes providing general EO process knowledge to Customers and holding regular Customer meetings to discuss study design and execution. The EO Analyst III provides guidance and mentoring to EO Analysts I and II.

What You’ll do as an EO Analyst III

Operational Excellence 80%

• Delivers Customer turnkey validation service(s) in the areas of validation cost, study design and management, laboratory coordination, and resultant documentation. 
  • Reviews and analyzes Customer product to determine appropriate biological challenges utilizing current FDA, ANSI, AAMI, ISO, EN (British) guidelines as well as historical data base and physical characteristics and limitations of devices.
  • Determines compatibility of devices to established EO processes utilizing historical data and manufacturer’s specifications and facility compatibility. 
  • Gathers relevant data from Customer and develops cost estimate that include cycle cost, consultation cost, preparation costs, as well as external laboratory cost. 
  • Executes the design of a sterilization process to ensure high quality validation. This includes identification of responsibilities, ensuring compliance, and associated documentation. 
    • Designs and coordinates scientific studies, collects data, performs data analysis, makes necessary adjustments, and puts it in a format using advanced statistics and physics. 
• Coordinates external laboratory activities in support of turnkey efforts (e.g., completes paperwork, ships overnight to other facilities, etc.). 
• Contributes to a team effort by performing in accordance with STERIS policies, GMP, Lean principles and other directives; supports the directives and decisions of higher-level management and performs other duties as assigned. 
• Provides to the processing facility a validated process which ensures sterility and is sustainable to facility operations.

People Leadership 10%

• Mentors EO Technology Center Analysts I and II, providing technical support by answering questions, providing guidance and direction.
• Fosters an environment for learning which ensures patient safety and compliance with regulatory bodies.

Customer Relations 20%

• Provides EO validation process education and counseling to internal and external Customers. Supports the Laboratory and collaborates with staff to understand process.
• Meets with Customers regularly to schedule loads, discuss products, design studies, etc.
• Provides Customers with continued counsel for the life of the product and/or cycle.
• Ensures validation programs are FDA ready for submission and review.
  

The Experience, Skills, and Abilities Needed

Required:

• Bachelor’s Degree in technical discipline or minimum 10 years related experience 
• Minimum of 5 years’ experience in EO operations, engineering, and/or cycle development medical device or pharmaceutical industry with a working knowledge in lab functions as they relate to EO product related procedures
• Knowledge of EO operations, engineering, and/or cycle development
• Knowledge of FDA and/or ISO
• Experienced in analyzing CUSTOMER and regulatory problems and using judgement to formulate corrective action plans and /or solutions

Other: 

• Skilled in the use of computers, including word processing, spreadsheet, and software capabilities
• Excellent CUSTOMER service, including managing and resolving service issues and complaints
• Strong ability to organize, prioritize, and manage time
• Well versed in Math (advanced algebra and/or calculus and/or statistics)
• Detail oriented
• Excellent verbal and written communication skills
• Experienced in mentoring and guiding peers
• Ability to work independently under general guidelines and supervision
• Collaborative team-oriented professional
• Oversees challenges with composure and adaptability
• Ability to influence people in their opinions, attitude, or judgments
• Capable of assessing situations and making informed decisions 
  

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. 

Here is a brief overview of what we offer:

• Market competitive pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits 
• Long/short term disability coverage
• 401(K) with company match 
• Maternity and parental leave 
• Additional add on benefits/discounts for programs such as pet insurance 
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career 

#LI-HT1

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047 . This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

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