Senior Computer System Validation Specialist

British American Tobacco•Winston-Salem, NC

3d•Onsite

About The Position

Reynolds American is evolving into a global multi-category business. Our purpose is to create A Better Tomorrow™ by Building a Smokeless World. To achieve our ambition, we are looking for colleagues who are ready to join us on this journey. Tomorrow can’t wait, let’s shape it together! REYNOLDS AMERICAN has an exciting opportunity for a Senior Computer System Validation Specialist in Winston-Salem, NC The Senior Scientist, Validation Compliance contributes to and executes validation processes for regulatory compliance initiatives across across RAI Operating Companies. The position manages change control activities for existing and new validations through cross-functional collaboration, ensuring compliance with governing procedures. The position participates in audits and provides backroom support during regulatory inspections.

Requirements

Bachelor of Science degree with 3+ years of relevant experience; Associate degree with 5+ years; or High School diploma/equivalent with 6+ years of relevant experience.
Hands-on experience executing Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities within a regulated environment.
Experience developing and executing validation deliverables, including validation plans, requirements and risk assessments, design/configuration specifications, scripted testing, IQ/OQ, and validation summary documentation.
Experience assessing computer systems, applications, interfaces, workflows, and data to determine validation requirements, identify gaps, and ensure systems operate as intended.
Knowledge of validation lifecycle, change control, software development lifecycle concepts, and applicable regulatory/compliance requirements.
Strong technical aptitude with the ability to quickly learn, understand, and evaluate different computer systems and technologies.
Ability to independently manage multiple priorities while maintaining strong attention to detail, process adherence, documentation quality, and timely execution.
Strong communication and cross-functional collaboration skills, with the ability to engage stakeholders at different organizational levels; proficiency in Microsoft Excel, Word, and PowerPoint, with familiarity with AI-enabled productivity tools such as Microsoft Copilot considered a plus.

Nice To Haves

familiarity with AI-enabled productivity tools such as Microsoft Copilot

Responsibilities

Contribute to and execute validation strategy, framework, processes and process governance for FDA and other regulatory compliance initiatives across RAI operating companies
Manage and execute validation and change control actitivies for validation projects, ensuring compliance with governing procedures
Develop and deliver presentations, communications, training material, and metrics to stakeholders at all levels of the organization
Participate in internal and external audits
Ensure and engage in cross-functional collaboration and consultation for existing, planned, and pending activities
Contribute to staffing and workload distribution discussions for validation, change control, and related activities
Manage and escalate validation-related issues, as appropriate
Serve as backroom support resource, providing validation deliverables during regulatory inspections

Benefits

401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation.
Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
Company contributes an additional three percent to 401(k) whether employee participates or not
Comprehensive health- and welfare-benefits package (including medical, dental, vision, and prescription drugs)
Health Savings Account start-up contribution for employees who elect the high deductible health plan
Flexible spending accounts for both Health Care and Dependent Care allowing employee to use pre-tax dollars to pay for qualified expenses during the calendar year
Employee assistance program offering 8 free counselling sessions, per issue, each calendar year for employees and their dependents
Company paid life insurance of 1x annual base pay ($50,000 minimum)
Company paid accidental death or dismemberment insurance of 2x annual base pay ($50,000 minimum)
Voluntary insurances offered at group rates: employee and dependent life insurance, AD&D insurance, critical illness, accident coverage, disability buy-up, and auto & home insurance
Tuition reimbursement and student loan support
Dependent Scholarship Programs
Free confidential personal financial counselling service
On-site health centers and 24/7 fitness centers at certain company locations
A charitable giving matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
Health-care concierge service
Volunteer service opportunities
Extensive training opportunities
Company vehicle for eligible employees
Mobile phone allowance for eligible employees
Paid Leave: Sick and Personal Time (exempt employees may be excused with pay for brief absences; non-exempt employees receive up to 6 days)
Vacation (levels Below Senior Director receive 15 days (pro-rated during first year of service); Senior Director and Officers receive 25 days (pro-rated during first year of service)).
Holidays (Nine company recognized and two annual personal holidays to be used at the employee’s discretion)
Paid Parental Leave + temporary reduced work schedule opportunity
Funeral Leave
Short-Term Disability Leave
Long-Term Disability Leave
Jury Duty Leave
Military Leave
Released Time for Children’s Education
Community Outreach Leave
Other paid leave benefits, as required by state or local law