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Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
As the company continues to grow we are seeking a Validation Scientist II, III (Multiple Openings). The Validation Scientist organizes and leads moderately complex validation projects primarily focused on the validation of new supplies of MicroSlide raw materials, such as those that are replacing materials that have been obsoleted by a supplier (e.g. chemicals and biologicals). This position will work both independently and as a team member to conduct root-cause investigations of factory production failures as needed. Defines and develops test designs to evaluate the failure on product performance and to assess residual product risk. Analyzes data and documents findings in technical reports including a recommendation for the fitness of use of the product.
This position is in Rochester, NY.
The ResponsibilitiesLeadership of multiple projects concurrently.
Plans, leads and documents feasibility trials for new raw materials and/or manufacturing materials.
Creates and/or updates existing risk assessments (e.g. FMEA and Product Hazard Analysis).
Writes validation plans and reports.
Implementation of validated materials into production.
Effectively communicates results to management and cross-functional teams; summarizes and presents project status updates to senior leadership team as needed.
Minimum BS degree in scientific field (Chemistry, Biology, Biotechnology, or Chemical Engineering field preferred); MS or PhD preferred.
Required Travel:>5%
3-5 years of experience working in regulated environment (FDA, ISO, UDSA, etc.)
Experience with VITROS MicroSlide technology required.
Experience with Ortho Change Control system required.
Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.
Demonstrated validation experience required; 2+ years preferred.
Strong organizational skills, ability to multi-task, and prioritize multiple projects.
5-7 years of experience working in regulated environment (FDA, ISO, UDSA, etc.)
Experience with VITROS MicroSlide technology required.
Experience with Ortho Change Control system required.
Experience with data analysis in VAX, LIMS, Excel and Minitab (or equivalent) required.
Demonstrated validation experience required; 2+ years preferred.
Strong organizational skills, ability to multi-task, and prioritize multiple projects.
EOE/AA Disability/Veteran
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"At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law."