Senior Computer System Validation Specialist

To achieve our ambition we are looking for colleagues who are ready to join us on this journey. Tomorrow cant wait lets 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.

Your key responsibilities will include:

• 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

What are we looking for

• 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.

WE ARE REYNOLDS AMERICANA member of the BRITISH AMERICAN TOBACCO GROUP

At Reynolds American we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at REYNOLDS AMERICAN.

BELONGING ACHIEVING TOGETHER

Collaboration and teamwork underpin everything we do here at Reynolds American. We know that collaborating with colleagues is what makes us stronger and best prepared to meet our business goals.

SALARY AND BENEFITS OVERVIEW

Benefit Information

The following is a general summary of the competitive compensation and benefit plans we offer:

• 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 ($50000 minimum)
• Company paid accidental death or dismemberment insurance of 2x annual base pay ($50000 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 employees 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 Childrens Education
• Community Outreach Leave
• Other paid leave benefits as required by state or local law

• Your journey with us is not limited by boundaries; it is propelled by your aspirations. Join us at Reynolds American and become a part of an environment that thrives on internal advancement where your career progression is not just a statement it is a reality we are eager to build together. Seize the opportunity and own your development; your next chapter starts here.
• You will have access to online learning platforms and personalized growth programs to nurture your leadership skills.
• We prioritize continuous improvement within a transformative environment preparing for ongoing changes.

Our organization offers a level of challenge responsibility and creativity for motivated employees who want to grow their are also committed to valuing different perspectives experiences and talents to improve the companys potential for optimally achieving its business objectives!

Reynolds American Inc. and its affiliated companies is an Equal Opportunity qualified applicants will receive consideration for employment without regard to age race color religionsex sexual orientation gender identity national origin protected veteran status disability status or any other status protected by law. Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly via email at

#LI-Hybrid

Required Experience:

Senior IC