CSV - Quality Systems Specialist
We are Reckitt
Research & Development
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 size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
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.
Your 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.
This role is not currently sponsoring visas or considering international movement at this time.
The experience we're looking for
- 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.
The skills for success
What we offer
US salary ranges
USD $85,000.00 - $127,000.00
Hiring range up to 100K
US pay transparency
Equality
Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount
Job Segment:
Counseling, Nutrition, Healthcare