Job Title:  Validation Engineer

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. 

Duties

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

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.