CSV - Validation Lead

TechDigital Group; Rahway (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

TechDigital Group in Rahway, NJ seeks a Senior CSV Validator for SAP systems in healthcare. Lead validation across SAP modules, create validation plans and ensure GMP/GxP compliance to deliver validated systems.

You will collaborate with QA, IT and business stakeholders to execute risk-based validation, IQ/OQ/PQ, and UAT, driving quality and compliance across the project lifecycle.

Qualifications

• CSV validation for SAP and healthcare applications.
• Experience with IQ/OQ/PQ protocols and validation reports.
• Knowledge of FDA 21 CFR Part 11 and GxP requirements.
• HIPAA regulatory compliance awareness.

Responsibilities

• Create, assign and track project module work plans and provide technical guidance.
• Ensure process improvement and compliance; participate in reviews.
• Create work plans, monitor schedule for on-time delivery.
• Prepare status reports to minimize exposure/risks and escalate as needed.
• Develop and guide team to enhance technical capabilities and productivity.

Skills

CSV for SAP systems/projects

Job description

Job Responsibilities

• To create, assign and track the project [module] work plans for delivery and also provide technical guidance for work completion.
• To ensure process improvement and compliance in the assigned module and participate in technical discussions/review.
• To create work plans, monitor and track the work schedule for on time delivery as per the defined quality standards.
• To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.
• To develop and guide the team members in enhancing their technical capabilities and increasing productivity.

Mandatory Skills

CSV for SAP systems/projects

Additional Requirements

• 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.