CSV - Quality Systems Specialist

Reckitt•Wilson, NC

12d•$85,000 - $127,000

About The Position

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The CSV Specialist is responsible for supporting the validation lifecycle of GxP-regulated computerized systems. This role ensures that enterprise systems such as LIMS, PAS-X, SAP and site digital platforms meet regulatory requirements and internal standards for data integrity, compliance, and operational effectiveness.

Requirements

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field with 3–5 years of Computer System Validation (CSV) experience in pharmaceutical or other highly regulated industries.
Hands-on experience executing the full validation lifecycle, including system validation, Computer Software Assurance (CSA), data integrity initiatives, and software development lifecycle (SDLC) activities.
Experience applying FDA regulations, GAMP 5, ICH Q7–Q10, 21 CFR Part 11, and other regulatory requirements to validated systems and compliance programs.
Proven experience supporting regulatory audits, inspections, and validation activities while maintaining compliant documentation in accordance with quality and regulatory standards.
Demonstrated success managing multiple validation projects, partnering with cross-functional teams, and driving compliance and continuous improvement initiatives in fast-paced environments.

Nice To Haves

Commercial Awareness
Business Partnership
Collaboration
Partnership building
Ability to challenge the status quo
Propose improvement
Accountability
Adaptability
Collaborator
R&D
Product Lifecycle Management

Responsibilities

Develop and execute Computer System Validation (CSV) deliverables, including URS, FRS, IQ/OQ/PQ protocols, validation reports, periodic reviews, and revalidation activities.
Ensure compliance with regulatory requirements and industry standards, including 21 CFR Part 11, Annex 11, GAMP 5, data integrity, SOPs, and CSA methodologies where applicable.
Support change controls, investigations, CAPAs, risk assessments, and audit/inspection activities while maintaining accurate, complete, and audit-ready validation documentation.
Partner with IT, Quality, and technical teams to implement, validate, and sustain compliant computerized systems and documentation processes.
Train end users on validated systems and CSV procedures, maintain SOPs and templates, and drive continuous improvement initiatives to enhance compliance, efficiency, and performance.