Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Job Title:
Microsoft D365 ERP Validation Consultant (Cloud Experience)
Note: Opportunity does not begin until May 2025, and it is short-term consulting.
Location:
Sanford, NC
Company:
Valspec
About Valspec:
Valspec 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.
Position Summary:
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.
Key Responsibilities:
- ERP Validation Planning and Execution: Develop, execute, and manage validation plans for Microsoft D365 implementations and upgrades to ensure regulatory compliance, particularly in the cloud.
- Compliance with Regulatory Standards: 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.
- Document Creation and Management: Create detailed validation documents, including validation plans, protocols (IQ, OQ, PQ), risk assessments, traceability matrices, and summary reports.
- Testing and Verification: Develop and execute test cases to verify system functionality, security, and compliance, addressing any discrepancies found in the validation process.
- User Training and Support: 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.
- Continuous Improvement: Identify areas for improvement in validation methodologies and processes, including leveraging automation tools and advanced testing methods to improve efficiency.
- Collaboration: 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:
- Education: Bachelor’s degree in Computer Science, Engineering, or a related field; relevant certifications in Microsoft D365 or ERP validation are a plus.
- Experience: 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.
- Technical 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.
- Soft Skills:
- 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
- Opportunity to work on impactful projects in a dynamic, growing company
How to Apply:
Please submit your resume, cover letter, and any relevant certifications or portfolio items.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.Valspec is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
