About the roleThe 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 successCommercial Awareness, Business Partnership, Collaboration, Partnership building, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Collaborator, R&D, Product Lifecycle Management.
What we offerWith 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.We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
US salary rangesUSD $85,000.00 - $127,000.00
Hiring range up to 100K
US pay transparencyThe 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.
