Senior Computer System Validation Specialist

We need to output HTML fragment with sections: About the role? Actually the posting includes description. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where posting has real specific content. We need to extract content. Let's parse: - Title: Senior Computer System Validation Specialist (but we don't repeat as heading). We'll have sections. - About the role: maybe a paragraph summarizing purpose. The posting starts: "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." This is about role. So we can put that in

About the role

with

paragraphs. - Responsibilities: The bullet list under "Your Key Responsibilities Will Include". We'll list each line as

. - Requirements: The "What are we looking for?" includes education/experience requirements and hands-on experience etc. That could be Requirements and Qualifications. We need to decide sections: maybe Requirements (education/experience) and Qualifications (skills). But we can combine if not enough distinct. However we need to follow instruction: include a section ONLY when posting has real specific content. We can have both Requirements and Qualifications if content distinguishes. Let's extract: Education/experience: "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 CSV/CSA within 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 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 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. These could be split: Requirements (education/experience) and Qualifications (skills/experience). But many of these are qualifications. Let's decide: - Requirements: education/experience baseline. - Qualifications: the hands-on experience, knowledge, skills. - Skills: maybe technical skills (Excel, Word, PowerPoint, Copilot). But we could also put under Qualifications. Given instruction to prefer few substantive sections over many thin ones, we might combine Requirements and Qualifications into one section? But we have headings list; we can choose to include only those with real content. Could do:

About the role

...

Responsibilities

...

Requirements

...

(education/experience + maybe hands-on experience?) But we need to preserve all substantive info. Let's try to allocate: About the role: first paragraph(s) describing company and role. Responsibilities: bullet list of responsibilities. Requirements: education/experience baseline. Qualifications: hands-on experience, validation deliverables experience, assessing systems, knowledge of lifecycle, technical aptitude, ability to manage priorities, communication skills. Skills: proficiency in Microsoft Excel, Word, PowerPoint, familiarity with AI-enabled productivity tools such as Microsoft Copilot considered a plus. Benefits: there is a big "Salary And Benefits Overview" with details. So we include Benefits section. Pay: not specified (no salary figure). So we should NOT include Pay section because no specific pay. Schedule: not specified. So no Schedule. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits. Now we need to format. We must not repeat job title as heading. Good. We must not include Job ID etc. We must remove boilerplate: EEO, etc. At end there is EEO statement and California Privacy Notice. Remove. Also remove "See what is possible for you at REYNOLDS AMERICAN." etc? That's maybe fluff but still substantive? It's generic marketing; but we can keep as part of About the role? Might be considered boilerplate. Safer to keep only role description. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "See what is possible..." is not exactly boilerplate but could be considered marketing fluff. Might keep? Safer to keep only the role description part. Let's extract About the role text: Up to "The position manages change control activities for existing and new validations through cross-functional collaboration, ensuring compliance with governing procedures." Also there is earlier sentence: "The Senior Scientist, Validation Compliance contributes to and executes validation processes for regulatory compliance initiatives across across RAI Operating Companies." We'll combine. Thus About the role paragraph: "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 RAI operating companies. The position manages change control activities for existing and new validations through cross-functional collaboration, ensuring compliance with governing procedures." Now Responsibilities list: each bullet from "Your Key Responsibilities Will Include". Let's list them exactly: - 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 activities 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 Make sure spelling: "actitivies" in original but we should preserve as is? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep the typo? It says "actitivies". Probably we should keep as is. However we might correct? The instruction says do not invent or summarize away detail. Changing a typo could be considered inventing? It's correcting a mistake, which could be altering. Safer to keep original text. So keep "actitivies". Also "Manages" vs "Manage"? We'll keep as given. Now Requirements: education/experience baseline. We'll put as

• 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.

But maybe also include "Hands-on experience executing Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities within a regulated environment." That's more qualification. We'll put under Qualifications. Qualifications: list items: - 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. Now Skills: proficiency in Microsoft Excel, Word, and PowerPoint, with familiarity with AI-enabled productivity tools such as Microsoft Copilot considered a plus. We'll put as

• Proficiency in Microsoft Excel, Word, and PowerPoint
• Familiarity with AI-enabled productivity tools such as Microsoft Copilot (considered a plus)

Now Benefits: we need to capture all benefit details from "Salary And Benefits Overview". Let's extract: - 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 We should preserve all. We'll put as

with each benefit as
• . Might be long but okay. We must not include Pay or Schedule sections.