CSV - Quality Systems Specialist

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., * 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.

• 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

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

The base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law. In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year. Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, and life and disability insurance; paid time off for vacation, sick and Company recognized holidays; a 401(k) plan; 16-week paid parental leave or 26 weeks for the birthing parent; adoption and fertility support; tuition reimbursement; discounts; and much more. Our compensation and benefits packages aim to give our talent the reward, protection, and peace of mind they deserve. If reasonable accommodation is needed to complete your application, please contact NAtalentacquisition@reckitt.com. Reckitt is committed to the full inclusion of all qualified individuals.

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.