Senior CSV Specialist — Compliance & Validation Leader

The British American Tobacco Group; Winston-Salem (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Life insurance

Tuition reimbursement

On-site health centers

Job summary

Reynolds American is seeking a Senior Computer System Validation Specialist in Winston-Salem, NC to strengthen our regulated validation programs across RAI operating companies. You will lead validation activities, ensure compliance, and support regulatory inspections.

You have hands-on CSV/CSA experience, strong collaboration skills, and the ability to translate complex requirements into plans, tests, and systematic documentation for internal and external audits.

Qualifications

• Hands-on experience executing CSV and/or CSA in a regulated environment.
• Experience developing and executing validation deliverables (plans, requirements, risk assessments, IQ/OQ, etc.).
• Assess computer systems to determine validation needs, gaps, and operation.
• Knowledge of validation lifecycle, change control, software development lifecycle and regulatory requirements.
• Strong technical aptitude and ability to learn and adapt quickly.

Responsibilities

• Contribute to and execute validation strategy, framework, and governance for FDA and other regulatory initiatives across RAI.
• Manage validation and change control activities ensuring procedures compliance.
• Develop and deliver presentations, communications, training materials, and metrics.
• Participate in internal and external audits.
• Engage in cross-functional collaboration for current and planned activities.
• Contribute to staffing and workload distribution for validation tasks.
• Elevate validation-related issues as appropriate.
• Serve as backroom support during regulatory inspections.

Skills

CSV experience

CSA experience

Regulated environment

Validation lifecycle

Audit support

Change control

Excel/Word/PowerPoint

Cross-functional collaboration

Strong communication

Education

Bachelor of Science degree with 3+ years of relevant experience

Associate degree with 5+ years of relevant experience

High School diploma/equivalent with 6+ years of relevant experience

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

AI-enabled productivity tools (Copilot)

Job description

Reynolds American is seeking a Senior Computer System Validation Specialist in Winston-Salem, NC to strengthen our regulated validation programs across RAI operating companies. You will lead validation activities, ensure compliance, and support regulatory inspections.

You have hands-on CSV/CSA experience, strong collaboration skills, and the ability to translate complex requirements into plans, tests, and systematic documentation for internal and external audits.