Steris Corporation Columbus OH United States
1 month ago
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.
Our Healthcare Customers are federally mandated (by Center for Medicare & Medicaid Services or CMS) requiring vendors to have the COVID-19 vaccination or an approved exemption. There are select Customers who do not accept any... exceptions. Unvaccinated Associates may be excluded from working at a Customer site, require routine testing with an approved exemption (if accepted by the Customer) or have limited Customer access impacting their ability to remain employed. Additionally, we may be required to meet state mandates on COVID-19 vaccination, exemptions and/or booster requirements. This position is a Customer-facing role that falls under a state or CMS mandate.
Do you enjoy providing validation services and working with different departments to train them on protocols? Join STERIS as the Senior Validation Engineer! In this role, you will be responsible for meeting Life Science Customer’s demands for validation services in cGMP regulated markets such pharmaceutical, biotechnology, medical device, and laboratory research. You will also provide leadership, training, write and execute quality validation protocols, consultative and technical support to Customers and STERIS Sales/Service associates.
You will be responsible for providing enhanced Life Science validation support and superior Customer service. Using sound knowledge, application and proper implementation of technical, quality and scientific principles, you write, execute and deliver all aspects of our validation services and communicate to our Customers during the entire validation process of their equipment. To be successful, you must possess a high level of knowledge of Industry Standard Validation procedures and written documentation and must have a strong understanding of the validation business, cGMP, GLP and regulatory requirements.
This position is home based (remote) with 40-50% Domestic travel required. 10% Global travel required.
What You Will Do
• Develop, author, execute Validation/Qualification protocols such as Cycle Development, Calibration, IQOQ, PQ to meet FDA regulations and SOP requirements of the Customer on Life Science equipment such as Steam Sterilizer, Pure Water Systems and Pharmaceutical Grade Washers/ Decontaminators and VHP Biodecontamination Systems. During the execution of protocols, identify and resolve any non-conformances/deviations/out of specification results.
• Interpret, analyze results and incorporate into a final summary report using Good Documentation Practices (GDP) according to cGMP requirements. (50%)
• 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. (10%)
• Develop validation project schedules and support all other project deliverables to meet deadlines and LS Specialty Engineering department standards. (10%)
• 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. (10%)
• Maintain current knowledge of regulatory and industry standards for validating LS equipment. (10%)
• Train other validation engineers to write, execute and summarize PQ projects and oversees their work. (10%)
• Bachelor's Degree in Electrical Engineering or Mechanical Engineering
What You Need To Be Successful
• Bachelor's Degree in Engineering required, open to various fields of study, Electrical, Mechanical, Biomedical, etc.
• 7+ years of demonstrated experience in Qualification/Validation of process equipment used in sterilization, critical utilities and instrument cleaning such as Steam Sterilizers, Pure Steam Generators, Pure Water Stills and cGMP Washing equipment using cGMP, ISPE, GAMP, ASTM and ICH guidelines.
• Experience with the following critical utility systems: HVAC, Electrical, Purified Water, Clean Steam and Compressed Air
• 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 interpreting techniques for Biological Indicators.
What Will Help You
• A proactive self-starter with motivation to provide strong deliverable quality and Customer experience.
• Excellent oral, written and interpersonal skills in a high pressure environment.
• Demonstrated leadership, 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 generation, interrupting 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.
• PLC programming would be a plus but not required for the position.
• Must have valid driver license and ability to obtain a passport.
What We Offer
The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
Our Healthcare Customers are federally mandated (by Center for Medicare & Medicaid Services or CMS) requiring vendors to have the COVID-19 vaccination or an approved exemption. There are select Customers who do not accept any exceptions. Unvaccinated Associates may be excluded from working at a Customer site, require routine testing with an approved exemption (if accepted by the Customer) or have limited Customer access impacting their ability to remain employed. Additionally, we may be required to meet state mandates on COVID-19 vaccination, exemptions and/or booster requirements. This position is a Customer-facing role that falls under a state or CMS mandate.
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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
Columbus OH USA
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Senior Validation Engineer (Steam Sterilization) - Home Based Columbus jobs
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