Validation Specialist

Experis; Raleigh (NC); Hybrid; USD 75,000 - 107,000; Full time

Benefits offered by this job

Medical and Prescription Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Plan

401(k) Plus Match

Weekly Pay

Job summary

ManpowerGroup, the leading global workforce solutions company, is seeking a Validation Specialist in Raleigh, NC. This hybrid role focuses on GxP validation of SaaS and modern software solutions within the R&D IT department, driving CSA-based validation strategy from planning through hypercare.

The candidate will apply GAMP 5 principles, write validation deliverables, and coordinate across technical and regulatory teams to ensure audit-ready documentation and regulatory readiness for submissions.

Qualifications

• Recent CSA experience with US and EU regulations, including US CFR and EU Annex 11.
• Subject matter expertise in CSA and GxP computerized systems, with practical experience applying GAMP 5 principles.
• Ability to write validation deliverables (validation plans, user requirements, testing documentation) and training documentation (User/Admin SOPs as applicable).
• Experience implementing and validating SaaS applications, with familiarity for electronic Instructions For Use and electronic Prescribing Information workflows.

Responsibilities

• Implement GxP computerized systems for R&D IT by applying GAMP 5 principles and CSA best practices to support compliant validation.
• Own validation strategy and execution by reviewing processes and procedures, leading/facilitating meetings, and aligning stakeholders on requirements, testing, and outcomes.
• Write and maintain validation and technical documentation, including validation plans, user requirements, testing documentation, change control support, and training materials.
• Support system implementation activities such as project configuration, user acceptance testing (UAT), and hypercare to maintain a validated state.
• Contribute to regulatory readiness by supporting regulatory intelligence, regulatory submission and deficiency management, and related documentation workflows.

Skills

CSA experience

GxP systems

Regulatory knowledge

UAT testing

Stakeholder collaboration

Job description

As a Validation Specialist, you’ll help ensure GxP computerized systems are implemented and maintained in a compliant way for the R&D IT department. If you’re energized by regulatory detail, structured validation work, and building confidence in SaaS and modern software solutions, this hybrid role in Raleigh is a great place to apply your Computer Software Assurance (CSA) expertise and drive validation strategy from planning through hypercare.

Job Title: Validation Specialist

Location: Raleigh, NC (Hybrid: Monday to Friday; 3 days in office)

Pay Range: $66/hr

What's the Job?

• Implement GxP computerized systems for R&D IT by applying GAMP 5 principles and CSA best practices to support compliant validation.
• Own validation strategy and execution by reviewing processes and procedures, leading/facilitating meetings, and aligning stakeholders on requirements, testing, and outcomes.
• Write and maintain validation and technical documentation, including validation plans, user requirements, testing documentation, change control support, and training materials.
• Support system implementation activities such as project configuration, user acceptance testing (UAT), and hypercare to maintain a validated state.
• Contribute to regulatory readiness by supporting regulatory intelligence, regulatory submission and deficiency management, and related documentation workflows.

What's Needed?

• Recent CSA experience with a strong understanding of relevant US and EU regulations, including US CFR and EU Annex 11.
• Subject matter expertise in computer software assurance (CSA) and GxP computerized systems, with practical experience applying GAMP 5 principles.
• Ability to write validation deliverables (e.g., validation plans, user requirements, testing documentation) and training documentation (e.g., User/Admin SOPs as applicable).
• Experience implementing and validating SaaS applications, with familiarity preferred for electronic Instructions For Use and electronic Prescribing Information workflows.
• Strong collaboration skills to lead discussions, interact with stakeholders, and build relationships across technical and regulatory teams.

What's in it for me?

• Work on high-impact validation work that supports compliant GxP computerized systems for R&D IT.
• Use your CSA and regulatory knowledge to shape validation strategy and execution across planning, testing, and hypercare.
• Contribute to documentation that strengthens audit readiness and supports regulatory submission workflows.
• Collaborate with stakeholders and drive user adoption through training and change management.
• Opportunity to deepen experience with SaaS validation and modern software assurance approaches, including AI model validation exposure (preferred).

Upon Completion Of Waiting Period Consultants Are Eligible For

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells. ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.