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CSV - Quality Systems Specialist

City: Wilson

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 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 ranges

USD $85,000.00 - $127,000.00

Hiring Range up to 100K

US pay transparency

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.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount
Job Segment: Counseling, Nutrition, Healthcare