CSV Engineer with SAP ERP

Title: CSV Engineer with SAP ERP

Location: Chicago, IL

Terms: Contract

Job Details:

• Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, and healthcare-specific requirements.
• Proficiency in validating SAP systems and associated healthcare applications, including creating and executing validation plans, protocols, and reports (IQ, OQ, PQ).
• In-depth knowledge of healthcare regulatory compliance, including HIPAA and other industry standards, to ensure validated systems meet operational and legal requirements.
• Experience in risk-based validation approaches, focusing on critical system functionalities and maintaining compliance while optimizing validation efforts.
• Strong understanding of SAP healthcare modules (e.g., MM, SD, FICO, EHS) and their integration with other systems to design effective validation strategies.
• Excellent problem-solving skills to identify, document, and resolve validation issues, ensuring systems operate reliably and meet compliance standards.
• Effective communication and collaboration skills to work with cross-functional teams, including quality assurance, IT, and business stakeholders, to ensure successful validation processes.
• Develop and execute comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports to ensure SAP systems and associated healthcare applications meet regulatory and operational requirements.
• Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA, by validating system functionalities and documentation processes.
• Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based validation strategies.
• Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results, ensuring systems function as intended in a healthcare environment.
• Identify and resolve validation issues, conducting root cause analyses and implementing corrective actions to maintain compliance and system reliability.
• Provide training and guidance on CSV processes to stakeholders, ensuring understanding and adherence to validation standards and best practices.
• Stay updated on healthcare regulations and validation trends, advising on improvements to validation strategies and ensuring the organization's systems remain compliant and efficient.
• Effective communication skills, both written and verbal, to collaborate with technical and non-technical stakeholders.
• Ability to work collaboratively in an agile development environment.
• Exposure to modern software development practices, such.