ERP (D365) Validation Consultant

Valspec—a global provider of system validation and lifecycle services—specializes in delivering comprehensive compliance and validation services for ERP, cloud, and other enterprise systems, helping clients achieve industry standards and regulatory compliance. We partner with a variety of sectors, including pharmaceutical, biotech, manufacturing, and other regulated industries.

About the role

As a Microsoft D365 ERP Validation Consultant with cloud experience, you will play a key role in ensuring the validation of ERP systems, particularly Microsoft D365, for regulated industries. You will be responsible for performing system validation and ensuring compliance with relevant regulatory standards and best practices, particularly in a cloud environment. Your expertise in Microsoft D365 and validation methodologies will help clients achieve and maintain compliance in an efficient and effective manner.

Responsibilities

• Develop, execute, and manage validation plans for Microsoft D365 implementations and upgrades to ensure regulatory compliance, particularly in the cloud.
• Ensure D365 deployments meet all relevant regulatory standards, such as FDA 21 CFR Part 11, GxP, and GDPR, by conducting risk assessments, validation testing, and documentation reviews.
• Create detailed validation documents, including validation plans, protocols (IQ, OQ, PQ), risk assessments, traceability matrices, and summary reports.
• Develop and execute test cases to verify system functionality, security, and compliance, addressing any discrepancies found in the validation process.
• Provide training to end-users and project stakeholders on validation processes, standards, and best practices. Support troubleshooting of any validation-related issues during and after implementation.
• Identify areas for improvement in validation methodologies and processes, including leveraging automation tools and advanced testing methods to improve efficiency.
• Work closely with cross-functional teams, including IT, QA, and operations, to support project goals, ensure smooth communication, and coordinate validation activities within project timelines.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field; relevant certifications in Microsoft D365 or ERP validation are a plus.
• 3-5 years of experience in ERP validation, with at least 2 years focused on Microsoft D365 in a cloud environment, ideally within regulated industries.

Skills

• Proficiency in Microsoft D365 ERP functionality and cloud-based implementations.
• Strong understanding of regulatory standards such as FDA 21 CFR Part 11, GxP, GDPR, and ISO standards.
• Experience in cloud environments and cloud compliance standards.
• Familiarity with automated testing and validation tools.
• Strong problem-solving and analytical skills.
• Excellent communication and documentation skills.
• Ability to work independently and manage time effectively.

Benefits

• Competitive salary
• Remote work options
• Professional development opportunities
• Health and wellness benefits
• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• Employee Stock Ownership Plan (ESOP)

Location: Sanford, NC. Candidates must be legally eligible to work in the United States without company sponsorship.