Job 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

Manage the Process Validation activities required to comply with current regulations. Drafts, reviews, approve and facilitate completion of Process Validation protocols. Executes or manages execution of validation protocols and reports. Facilitates resolution of deficiencies that prevent successful validation of processes, conducts engineering testing, internal audits, equipment review, measurements, etc. Works closely with Engineering and Quality to ensure process validation plans are performed according to schedule.

This position can be worked remotely with an expected 50% travel requirement.

What You'll do as a Senior Test & Validation Engineer

• Write process equipment validations, which would include (IQ, OQ, PQ) and the Final Report.
• Work closely with Engineering and Quality to complete the process validation of manufacturing equipment. This includes VMPs, URS, and other related documents to the Project Management Project process.
• Conduct DOE’s, R&R, Capacity Studies, Sampling plans.
• Conduct PFMEA’s.
• Coordinate Engineering, Quality and Manufacturing staff to support the required validation.
• Ensure that transfers of R & D projects meet equipment validation requirements.
• Initiate and evaluate all available technical data in order to develop conclusions derived from studies undertaken. Provide analysis, evaluation, and interpretation of data.
• Utilize appropriate project management skills and tools to meet timelines and provide progress updates to management.
• Periodically monitor existing validations and update/modify as conditions change.
• Other duties as assigned which may include process development, project management, process optimization projects or other duties to optimize the plant operations.

The Experience, Skills and Abilities Required

Required Experience:

• Bachelor’s Degree in Engineering with a minimum 5-7 years of Process Validation experience or equivalent plant/process engineering experience that is demonstrated to add value to this position.
• Requires excellent interpersonal skills and strong team orientation.
• Requires excellent analytical, oral, and written communication skills.
• Proven record of facilitating project teams to achieve target goals and delivery timelines.

Preferred Experience:

• 3-5 years of experience in Quality and/or Regulatory
• 1-2 years of experience in Plant/Process Engineering

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Pay range for this opportunity is $90,737.50 - $117,425.00. 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 location’s HR Office during normal business hours.

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