Computer Systems Validation (CSV) Engineer

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

As a member of the Quality Operations team, the CSV Engineer will lead the validation of relevant computer systems to ensure compliance with global regulatory requirements (FDA, ISO, EU MDR, etc.). This role will drive validation strategy and execution across systems used in manufacturing, quality, supply chain, and enterprise platforms (e.g., SAP, Cornerstone, SmartSolve), ensuring data integrity, system reliability, and regulatory readiness. This team member will apply proven analytical and problem-solving skills to help validate, verify, communicate, and resolve system / software application issues through careful testing to maximize the benefits of system / software investments and initiatives. Additional expectations include participation in the development process for the medical device products including requirements, design, implementation, verification and validation and the associated documentations. The CSV Engineer will work in partnership with cross-functional teams including IT, Quality, Engineering, and Compliance to validate enterprise and manufacturing support systems.

What you'll be doing

• Participate in the system / software development process for the medical device products, including requirements definitions, design and implementation, verification, and validation testing.
• Lead the planning, coordination, and execution of Computer System Validation (CSV) efforts for new and existing GxP-regulated systems.
• Development of Computer System Validation specifications and artifacts including : Validation Plans, OQ / PQ protocol, risk / hazard assessments, trace matrixes, test scripts, training protocols, deviation plans, final summary / reports.
• Support Quality in ensuring systems used for product release, training, complaint handling, CAPA, and document control are properly validated.
• Collaborate with software vendors, system owners, and IT to ensure validation deliverables align with business and regulatory needs.
• Execution of OQ and PQ protocols and collection of required test evidence.
• Participate in the system / software verification and validation activities and write required documents per system / software development process including requirements, design, unit test, Engineering reports, verification and validation plan and report.
• Liaise with network administrators and software engineers to assist with quality assurance, program logic, and data processing.
• Liaise with the company’s software and hardware suppliers for prompt rectification of any problems or emergencies.
• Analyze documentation and technical specifications of any new application under deployment or consideration to determine its intended functionality.
• Evaluate, plan, design, develop, and deploy testing techniques for new applications, products, and / or enhancements to existing applications throughout their development / product lifecycles.
• Review and analyze the effectiveness and efficiency of existing systems and develop testing strategies for improving or leveraging these systems.
• Contribute to pre-testing phase of project development by evaluating proposals to identify potential problem areas and make appropriate recommendations.
• Create and execute test scripts, cases, and scenarios that will determine optimal system performance according to specifications.
• Collaborate with analysts, designers, and system / software owners in the testing of new software programs and applications.
• Communicate test progress, test results, and other relevant information to project stakeholders and management.
• Conduct all types of application testing as needed, such as system, unit, regression, load, and acceptance testing methods.
• Ensure that testing activities will allow applications to meet business requirements and systems goals, fulfill end-user requirements, and identify and resolve system issues.
• Ensure that any new software integration into company systems meets functional requirements, system compliance, and interface specifications.
• Analyze formal test results to discover and resolve defects, bugs, errors, configuration issues, and interoperability flaws.
• Produce reports and documentation for all testing efforts, results, activities, data, logging, and tracking.
• Develop, distribute, and coordinate in-depth end-user reviews for modified and new systems or applications.
• Cultivate and disseminate knowledge of application testing best practices. Take an active role in cross-departmental projects when needed.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Other duties as assigned.

What you'll bring to the table

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