Reckitt

1 week ago

CSV - Quality Systems Specialist (Wilson, NC, US, 27893)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Own the validation lifecycle for GxP-regulated computerized systems, ensuring enterprise platforms like LIMS, PAS-X, and SAP meet regulatory and data integrity requirements. Develop CSV deliverables (URS, FRS, IQ/OQ/PQ, reports, reviews, revalidation), support change controls, investigations, CAPAs, and audits, and partner with IT and Quality to implement compliant processes. Train end users and maintain audit-ready SOPs and templates while driving continuous improvement.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key 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 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, 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 and performance.

Pay and Benefits

Salary: USD 85,000 - 127,000 annually

Perks:Health InsurancePrescriptionDentalVisionLife InsuranceDisability InsurancePaid Leave401kParental LeaveAdoption SupportDiscountsLife Assistance

Key Requirements

•Bachelor’s degree in Computer Science, Engineering, Life Sciences, or 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 SDLC activities.
•Experience applying FDA regulations, GAMP 5, ICH Q7–Q10, and 21 CFR Part 11 to validated systems and compliance programs.
•Proven experience supporting regulatory audits, inspections, and validation activities while maintaining compliant documentation.
•Demonstrated ability managing multiple validation projects while partnering cross-functionally and driving continuous improvement in fast-paced environments.

Experience:3-5 yearsPharmaceuticalHighly regulated industriesGxP

Education:Bachelor's

Skills:Commercial awarenessBusiness partnershipCollaborationAccountabilityAdaptability

Tech Stack:LIMSPAS-XSAPSDLCSOPs

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Reckitt

Global consumer goods company producing health, hygiene, and home products across well-known brands. Operates in multiple markets offering over-the-counter health, personal care, and household cleaning products to consumers worldwide.

Industry: FMCG

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Slough, United Kingdom

Founded: 1999

Website LinkedIn

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Reckitt

1 week ago

CSV - Quality Systems Specialist (Wilson, NC, US, 27893)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key 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 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, 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 and performance.

Pay and Benefits

Salary: USD 85,000 - 127,000 annually

Perks:Health InsurancePrescriptionDentalVisionLife InsuranceDisability InsurancePaid Leave401kParental LeaveAdoption SupportDiscountsLife Assistance

Key Requirements

•Bachelor’s degree in Computer Science, Engineering, Life Sciences, or 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 SDLC activities.
•Experience applying FDA regulations, GAMP 5, ICH Q7–Q10, and 21 CFR Part 11 to validated systems and compliance programs.
•Proven experience supporting regulatory audits, inspections, and validation activities while maintaining compliant documentation.
•Demonstrated ability managing multiple validation projects while partnering cross-functionally and driving continuous improvement in fast-paced environments.

Experience:3-5 yearsPharmaceuticalHighly regulated industriesGxP

Education:Bachelor's

Skills:Commercial awarenessBusiness partnershipCollaborationAccountabilityAdaptability

Tech Stack:LIMSPAS-XSAPSDLCSOPs

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Reckitt

Industry: FMCG

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Slough, United Kingdom

Founded: 1999

Website LinkedIn