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
At STERIS were dedicated to creating a healthier and safer world by providing innovative healthcare and life science solutions globally. Were currently seeking a talented Validation Engineer to join our team. If youre passionate about validation enjoy travel and want to be a subject matter expert this role might be perfect for you! As a Validation Engineer at STERIS youll play a crucial role in ensuring the reliability and compliance of our products in cGMP-regulated markets. Youll author and execute validation protocols for STERIS equipment while also providing consultative support and training to our Service Representatives and Customers. Your expertise will contribute to the development and delivery of validation-related services across pharmaceutical biotechnology medical device and laboratory research sectors. If youre ready to contribute to our mission and thrive in a dynamic environment wed love to hear from you!
Note: Remote role with 40% travel to customer sites (some international); local candidates near Cleveland/Mentor OH preferred.
What Youll Do As A Validation Engineer
- Develop author and execute Validation/Qualification protocols (including Cycle Development IQOQ and PQ) for STERIS Life Science (LS) equipment adhering to STERIS Service and Customer requirements.
- Identify and resolve non-conformities during protocol execution analyze results and create final summary reports using Good Documentation Practices (GDP).
- Collaborate with Customers to define Scope of Work for formal PQ quotes and protocols based on Customer-defined load configurations.
- Create validation project schedules and support other project deliverables to meet deadlines and maintain department standards.
- Work with Specialty Services Engineering to establish validation standards procedures guidelines and best practices for Life Science equipment.
- Stay informed about regulatory and industry standards for validating LS equipment.
- Train Field Service Engineers on executing standard PQ protocols and oversee their work.
The Experience Skills and Abilities Needed
Required:
- Bachelors Degree in Mechanical Engineering Bio Medical Bio engineering Chemical or Engineering General is required.
- Minimum one (1) 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).
- Proficiency in electronic/electromechanical and computer-controlled equipment.
- Demonstrated cGMP (GDP) documentation skills.
- Experience with Kaye Validator or equivalent for thermal mapping of chambers and heat penetration studies.
- Understanding of appropriate handling and interpretation techniques for Biological Indicators.
- Proactive self-starter with a commitment to delivering high-quality results and ensuring a positive Customer experience.
- Willingness to travel up to 50%
- Strong organizational analytical and problem-solving abilities.
- Effective prioritization and project management skills.
- Background in generating interpreting and compiling raw measurement data into validated PQ records and final reports.
- Solid understanding of pharmaceutical CGMPs FDA regulations and other relevant requirements.
- Proficiency in Microsoft Office.
Pay range for this opportunity is $69000.00 -$78200.00. This position is eligible for bonus participation.
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.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
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 and life sciences products and services around the globe. For more information visit
.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 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 locations HR Office during normal business hours.
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 At STERIS were dedicated to creating a healthier and safer world by providing innovative healthcare and life science ...
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
At STERIS were dedicated to creating a healthier and safer world by providing innovative healthcare and life science solutions globally. Were currently seeking a talented Validation Engineer to join our team. If youre passionate about validation enjoy travel and want to be a subject matter expert this role might be perfect for you! As a Validation Engineer at STERIS youll play a crucial role in ensuring the reliability and compliance of our products in cGMP-regulated markets. Youll author and execute validation protocols for STERIS equipment while also providing consultative support and training to our Service Representatives and Customers. Your expertise will contribute to the development and delivery of validation-related services across pharmaceutical biotechnology medical device and laboratory research sectors. If youre ready to contribute to our mission and thrive in a dynamic environment wed love to hear from you!
Note: Remote role with 40% travel to customer sites (some international); local candidates near Cleveland/Mentor OH preferred.
What Youll Do As A Validation Engineer
- Develop author and execute Validation/Qualification protocols (including Cycle Development IQOQ and PQ) for STERIS Life Science (LS) equipment adhering to STERIS Service and Customer requirements.
- Identify and resolve non-conformities during protocol execution analyze results and create final summary reports using Good Documentation Practices (GDP).
- Collaborate with Customers to define Scope of Work for formal PQ quotes and protocols based on Customer-defined load configurations.
- Create validation project schedules and support other project deliverables to meet deadlines and maintain department standards.
- Work with Specialty Services Engineering to establish validation standards procedures guidelines and best practices for Life Science equipment.
- Stay informed about regulatory and industry standards for validating LS equipment.
- Train Field Service Engineers on executing standard PQ protocols and oversee their work.
The Experience Skills and Abilities Needed
Required:
- Bachelors Degree in Mechanical Engineering Bio Medical Bio engineering Chemical or Engineering General is required.
- Minimum one (1) 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).
- Proficiency in electronic/electromechanical and computer-controlled equipment.
- Demonstrated cGMP (GDP) documentation skills.
- Experience with Kaye Validator or equivalent for thermal mapping of chambers and heat penetration studies.
- Understanding of appropriate handling and interpretation techniques for Biological Indicators.
- Proactive self-starter with a commitment to delivering high-quality results and ensuring a positive Customer experience.
- Willingness to travel up to 50%
- Strong organizational analytical and problem-solving abilities.
- Effective prioritization and project management skills.
- Background in generating interpreting and compiling raw measurement data into validated PQ records and final reports.
- Solid understanding of pharmaceutical CGMPs FDA regulations and other relevant requirements.
- Proficiency in Microsoft Office.
Pay range for this opportunity is $69000.00 -$78200.00. This position is eligible for bonus participation.
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.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
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 and life sciences products and services around the globe. For more information visit
.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 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 locations HR Office during normal business hours.
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Job Location:
Monthly Salary:
$ 69000 - 78200
Posted on:
15 hours ago
Vacancies:
1 Vacancy
