Job Title:  Validation Engineer

Req ID:  37493
Job Category:  Engineering

Charlotte, NC, US, 28027


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 Validation Engineer is responsible for the development, execution of, and reporting on delivery of validation-related services in compliance with cGMP regulated market regulations for; healthcare, pharmaceutical, biotechnology, medical device and laboratory research.  The position’s primary responsibility is the authoring and execution of validation protocols, and generating final Validation reports for STERIS equipment within Offsite Reprocessing Centers (ORC). It is also expected that the Validation Engineer can function as a subject matter expert on all aspects of the validation process, including commissioning, calibrations, IQ/OQ/PQ, and providing consultative support and training to both STERIS Service Representatives and Customers as well. This role will include up to 50%-60% nationwide overnight travel. 


1.    Interface with Regulatory and Quality Control to define and assist in implementing product, process or equipment upgrades, enhancements, and/or service procedure revisions. 

2.    Support Validation/Qualification protocols including Cycle Development, IQ, OQ, and PQ on STERIS equipment according to STERIS and Customer requirements.  During the execution process, identify and resolve any non-conformities or descrepancies, analyze results and incorporate into a final summary report using Good Documentation Practices (GDP). 

3.    Work with internal and exsternal Customers to define Scope of Work for the development of a formal PQ protocol using  defined load configurations of the on site equipment. 

4.    Aid in development of and adhere to validation project schedules. Support all other project deliverables to meet scheduled completion dates and required standards. 

5.    Work with Quality and Regulatory to develop validation standards, procedures, guidelines and best practices which includes exploring new techniques, methods, and other industry practices on STERIS equipment.  

6.    Support STERIS Equipment Validation/Qualification and Service program, and  all program deliverables to meet target completion dates and department standards.

7.    Assure equipment and instrument calibrations are current and aid in maintenance of the calibrated state of the equipment and instruments where possible.

8.    Perform facility and equipment commissioning activities when required.

9.    Additional Duties as assigned to ensure business success.

Education Degree

Bachelor's Degree in Engineering General or Science

Required Experience

1.    2 years of demonstrated experience in Qualification/Validation of process equipment with a Bachelor's degree including; Steam Sterilizers, Ultrasonics, and Washing equipment using GMP, ISPE, GAMP, ASTM and ICH guidelines OR 4 years of demonstrated experience in Qualification/Validation with a high school diploma/GED.
2.    Experience with the following critical utility/mechanical systems: HVAC, Electrical, Purified Water, Clean Steam and Compressed Air desired.
3.    Work experience with both electronic/electromechanical and computer controlled equipment.
4.    Demonstrated cGMP (GDP) documentation proficiency.
5.    Experience in thermal mapping of chambers and heat penetration studies of loads.
6.    Understanding of appropriate handling and interpretation techniques for Biological Indicators.

 Pay range for this opportunity is $67.060,00 - $90.279,00. This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.


Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.


Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability.  Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.


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.

Req ID:  37493
Job Category:  Engineering

Charlotte, NC, US, 28027

Nearest Major Market: Charlotte
Nearest Secondary Market: Concord

Job Segment: Facilities, Medical Device Engineer, Thermal Engineering, Pharmaceutical, Infection Control, Operations, Engineering, Science, Healthcare