CSV - Quality Systems Specialist
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.
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.
- 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.
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.
Skills
- Commercial Awareness
- Business Partnership
- Collaboration
- Partnership building
- Ability to challenge the status quo
- Propose improvement
- Accountability
- Adaptability
- Collaborator
- R&D
- Product Lifecycle Management
Benefits
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
- Parental benefits, including 16-week paid parental leave or 26 weeks for the birthing parent
- Employee Assistance Program to promote mental health
- Life insurance for all employees globally
- 401(k) plan
- Paid time off for vacation, sick, and Company recognized holidays
- Adoption and fertility support
- Tuition reimbursement
- Discounts
- Global share plans to save and share in Reckitt's potential future successes
- Short-term incentives to recognise and reward outstanding results
- Competitive benefits including medical, prescription, dental, and vision insurance
Pay
US salary ranges: USD $85,000.00 - $127,000.00. Hiring range up to $100K.
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.