Computer System Validation Specialist

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.

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.