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CSV - Quality Systems Specialist

Job in Wilson, Wilson County, North Carolina, 27893, USA
Listing for: Reckitt
Full Time position
Listed on 2026-03-03
Job specializations:
  • Quality Assurance - QA/QC
    Data Analyst
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below

We are Reckitt Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development 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 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.

This role is not currently sponsoring visas or considering international movement at this time.

Your Responsibilities Computer System Validation (CSV)
  • Develop and execute CSV deliverables (URS, FRS, IQ/OQ/PQ, validation reports)
  • Support CSA implementation where applicable
  • Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity policies
  • Maintain validation documentation per SOPs and regulatory standards
  • Perform periodic system reviews and revalidation
Quality Assurance Support
  • Partner with IT, QA, and technical teams to ensure audit‑ready validation activities
  • Support change control, including impact assessments and documentation
  • Participate in audits/inspections and provide required CSV documentation
  • Assist with investigations, CAPAs, and risk assessments
Training & Documentation
  • Train end users and super users on validated systems and CSV procedures
  • Maintain system SOPs and validation templates
  • Contribute to continuous improvement of CSV processes and documentation
Performance & Outcomes
  • Deliver compliant execution aligned with performance targets
  • Support successful internal and external inspections
  • Collaborate effectively across teams
  • Ensure accurate, complete validation documentation
The experience we're looking for
  • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
  • 3–5 years of CSV experience in pharmaceutical or regulated industries
  • Strong knowledge of GAMP 5, FDA regulations, data integrity, and validation principles
  • Proficient with validation tools
  • Strong analytical, documentation, and communication skills
  • Solid understanding of SDLC and the validation lifecycle
  • Expertise in FDA, ICH Q7–Q10, GAMP 5, and data integrity guidelines
  • Experience with validated systems and CSA/data integrity requirements
  • Excellent documentation and organizational abilities
  • Able to work independently and collaboratively in fast‑paced environments
  • Experience supporting audits and regulatory inspections
  • Detail‑oriented with strong quality and compliance focus
  • Strong interpersonal and communication skills
  • Proactive problem solver with continuous improvement mindset
  • Skilled at prioritizing and managing multiple validation projects
The skills for success

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

What we offer

With…

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