Verista, Inc.

Engineer

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches
• Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory compliance.
• Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
• Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.
• Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
• Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.
• Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

CSA Consultant – Senior Validation Engineer

Data Analyst

• Provide CSA / CSV subject matter expertise across Data Analytics, AI, Machine Learning, and Digital platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Assess AI/ML solutions and analytics platforms to determine appropriate risk-based assurance activities
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, Data Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches for analytics and AI-enabled solutions
• Support supplier assessments, vendor documentation reviews, and leveraging of vendor testing where appropriate

Lead Validation Engineer, Data Analytics/AI

• Independently understand client’s quality standards, cGMP’s and regulatory standards to support team in compliance of validation effort.
• Design validation plans.
• Conduct independent verification of testing against specifications.
• Conduct and document impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
• Complete user interface testing, software verification, and complete alarm testing on automated systems.
• Develop, review, and execute testing documentation.
• Make recommendations for design or process modification based on test results when executing test scripts.
• Work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
• Support clients change management program – including author proposed changes, execute impact assessments/ regression analysis and support client documentation of change results and release.
• Maintain (and ensure the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.

Validation Engineer – Level 2

Sales Operations Manager

• Provide day-to-day support to the Sales Operations team
• Maintain and update Salesforce records, including tracking opportunities, projects, and customer data
• Assist in preparing and reviewing sales forecasts, incorporating inputs from representatives, regions, and leadership, and updating data as business conditions change
• Compile and distribute weekly, biweekly, monthly, and quarterly sales reports to appropriate stakeholders
• Support the creation and maintenance of dashboards, ensuring data accuracy and timely updates
• Assist in analyzing sales performance and preparing presentation materials for leadership
• Ensure accuracy and consistency of data across reports, systems, and Investigate reasons for changes from prior reports
• Notify appropriate stakeholders of any changes
• Support the administration of the Sales Referral Program, ensuring submissions are accurate and properly tracked
• Coordinate with Operations and Talent Acquisition to help align resource availability with projected sales activity
• Participate in regional and national sales meetings, providing reporting and operational support as needed
• Collaborate with IT, Sales, and Operations to support improvements in Salesforce functionality, tools, reporting, and analytics
• Perform other duties as assigned

Sales Operations Analyst

• Lead development of the validation strategy within the first 30 days of onboarding
• Oversee CSA/CSV compliance execution aligned with the customer SDLC and quality procedures
• Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary)
• Ensure readiness for formal testing and completeness of change control documentation
• Support CMDB governance and provide guidance on validation and testing tools
• Monitor KPI adherence including approval cycle time and traceability coverage

Senior CSV Engineer, Senior Validation Engineer

Analyst

• Support application transfer verifications to confirm qualified system state following migration or modernization
• Perform infrastructure qualification and validation documentation review, upload, and approval activities
• Assist technical teams in navigating CSA, validation, and compliance lifecycle requirements
• Contribute to qualification and verification of new systems and tools introduced through the Tech Mod program
• Support application modernization qualification and validation activities
• Assist with change management documentation and compliance alignment
• Help maintain traceability, risk assessment, and validation deliverables as directed by the CSA Lead
• Ensure work aligns with SDLC, data integrity, and documentation quality expectations

CSA-CSV Analyst – Validation Engineer

Accountant

• Responsible for end-to-end project accounting activities, including billing, collections, cash application, expense/vendor processing, and financial reporting for assigned accounts.
• Establish projects in FinancialForce by validating Salesforce data and ensuring all supporting documentation (SOWs, POs, and related contract materials) is complete and aligned to billing requirements.
• Complete time and materials billing for assigned accounts, ensuring accurate invoices of billable hours and expenses in accordance with contract terms.
• Drive collections by tracking invoices in customer portals, reconciling hours and expenses to Salesforce, resolving discrepancies, and partnering with customer A/P to expedite payment.
• Manage cash applications by posting receipts, applying payments to invoices, and processing customer discounts and adjustments as appropriate.
• Review and process expense reports and vendor invoices allocated to assigned projects.
• Prepare revenue and project profitability reports for assigned customer accounts.
• Ensure compliance with internal accounting controls and established A/P and A/R policies.
• Maintain general ledger integrity through accurate and timely recording of monthly transactions.
• Partner with operations to enhance Salesforce functionality and implement automation to improve process efficiency.
• Other duties as assigned.