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 we continue to grow, we are seeking a Sr. Validation Engineer (Quality). As the Sr. Validation Engineer (Quality), you will support all areas of Validation including product and process validation, equipment qualification (including continued process verification) and software and spreadsheet validation. Authors, reviews, executes and supports all site validations and associated documentation.

• Authors, reviews and/or approves validation documentation including protocols, reports and other sources of information to ensure that validations and procedures are consistent with current industry standards and regulatory requirements.

• Ensures that validation and qualification activities are consistent with company validation policies and procedures.

• Proceeds according to the company's quality policy in all business activities with providers and customers within and outside the company.

• Gain an understanding of statistical process controls (SPC),the DMAIC process and other quality and manufacturing investigative tools.

• Working with cross-functional teams, including technical and non-technical work.

• Organize and present technical information with minimal assistance.

• Provides training and guidance on aspects of validations and qualifications.

• Support the Quality system and Change Management processes.

• Participates in cross functional meetings related to changes in processes and products, process improvements and implementation of corrective actions.

• Contributes to the development, implementation and execution of quality systems in support of design and developmental studies.

• Supports Quality Engineers as needed by documenting and investigating nonconformance events and supporting root cause investigations (RCI) and CAPA.

• Participates in internal and external audits which may include all areas of support and audit readiness tasks.

• Archival of validation documentation following company record retention procedures.

• Maintenance and calibration of validation equipment (to be performed by outside vendor).

• Tracks and trends quality data for management review. May also include presentation of data to a large group.

• Perform other work-related duties as assigned.

• Bachelor's Degree in any discipline required; relevant technical discipline preferred.

• 1 - 3 years of experience working in a similar industry as a Validation Engineer.

• Demonstrates a basic understanding of the Product Engineering and Quality Management System concepts.

• Familiar with Computer/Software/Systems preferred.

• Experience with Biomedical Engineering/Mechanical Engineering/Automation a plus.

• Prior experience in Medical Technology/Biology/Chemistry or associated science preferred.

• Prior experience in Medical Device, Pharmaceuticals, Life Sciences or Laboratory systems processes / projects preferred.

• Up to 10% travel - Domestic or International may be required.

Key Working Relationships

• Internal - Coordination and collaboration with Manufacturing, Engineering, Quality Assurance and Product Support personnel for all aspects of the duties listed above.

• External - Communication with external suppliers, vendors and regulators as required. In the rare event contact with customers may be needed.

EOE/AA Disability/Veteran