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Job Title:  Validation Engineer

Req ID:  22145
Job Category:  Engineering
Country/Region:  US
State:  IL
City:  Chicago
Zip:  60611
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

Does your ideal job include significant travel (50%) and being considered a subject matter expert?  Then join the STERIS team as a Validation Engineer who authors and executes validation protocols on STERIS equipment but also functions as a subject matter expert on all aspects of the validation process, providing consultative support and training to both STERIS Service Representatives and Customers as well. You will also be responsible for the development and delivery of validation-related services in cGMP regulated markets including; pharmaceutical, biotechnology, medical device and laboratory research.  

Duties

  • Develop, author and execute Validation/Qualification protocols including Cycle Development, IQOQ, and PQ on STERIS Life Science(LS) equipment according to STERIS Service and Customer requirements.  During the execution process, identify and resolve any non-conformities, analyze results and incorporate into a final summary report using Good Documentation Practices (GDP). 
  • Work with Customers to define Scope of Work for the development of a formal PQ quote and protocol using Customer defined load configuration on Life Science equipment. 
  • Develop validation project schedules and support all other project deliverables to meet deadlines and Specialty Engineering department standards.
  • Work with Specialty Services Engineering to develop validation standards, procedures, guidelines and best practices which includes exploring new techniques, methods, and other industry practices on Life Science equipment. 
  • Maintain current knowledge of regulatory and industry standards for validating LS equipment.
  • Train Field Service Engineers on executing standard PQ protocols and oversees their work.

Education Degree

Bachelor's Degree in Mechanical Engineering or Engineering General

Required Experience

Experience needed
⦁    Minimum three (3) to five (5) years of demonstrated experience in Qualification/Validation of process equipment including; Steam Sterilizers, Pure Steam Generators, Pure Water Stills and cGMP Washing equipment using cGMP, ISPE, GAMP, ASTM and ICH guidelines preferred.
⦁    Work experience in both electronic/electromechanical and computer controlled equipment.
⦁    Demonstrated cGMP (GDP) documentation proficiency.
⦁    Extensive Kaye Validator experience in thermal mapping of chambers and heat penetration studies of loads.
⦁    Understanding of appropriate handling and interpretation techniques for Biological Indicators.


Skills needed

  • A proactive self-starter with motivation to provide strong deliverable quality and a positive Customer experience.
  • Desire to travel required. Must have valid driver license and ability to obtain a passport. Travel to Customer sites will include overnight stays.  May be subject to Customer drug testing, Customer specific safety training, or Customer SOP training.  Flexible scheduling may be required to accommodate Customer needs.  Weekend work could be required under certain situations.
  • Excellent oral, written and interpersonal skills in a high pressure environment.
  • Demonstrated strong organizational, analytical and problem solving skills with ability to make critical decisions on a routine basis. High level of attention to detail and driven towards results.
  • Ability to effectively prioritize and manage multiple project tasks to meet targeted deadlines.
  • Must have an appropriate background for generating, interpreting and compilation of raw measurement data into validated PQ records and final reports.
  • Must have experience and solid understanding of pharmaceutical cGMPs, FDA regulations and other regulatory requirements.
  • Computer skills: proficient in Microsoft Office.

#LI-KW1

 

STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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.


Nearest Major Market: Chicago

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