V
6375 - Data Analytics/AI Validation Engineer / Lead Validation Engineer
Accepting applicationsVerista · King of Prussia, PA
Full-Time Mid_senior AIMachine LearningSicSocai
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Job Overview: We are seeking a Lead CSV/CSA Engineer to support GxP compliance activities across Data Analytics, Artificial Intelligence (AI), Machine Learning (ML), and Digital platforms. This role will work closely with Quality, IT, Data Analytics, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations, internal procedures, and data integrity requirements.
Lead Validation Engineer Responsibilities:
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
Requirements:
5–8 years of hands-on experience supporting GxP systems, Data Analytics platforms, Artificial Intelligence solutions, or a combination of these domains
Hands-on experience supporting cloud-based, SaaS, COTS, or enterprise data platforms in regulated environments
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH), data integrity requirements, and ALCOA+ principles
Familiarity with AI, Machine Learning, advanced analytics, or business intelligence platforms
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality, IT, Data, and business stakeholders
Experience Machine Learning, Business Intelligence, Data Lake, Data Warehouse, or Digital Transformation platforms preferred
Experience with technologies such as Power BI, Tableau, Snowflake, Databricks, Azure, AWS, Google Cloud, or similar platforms preferred
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms preferred
Experience supporting AI governance, model lifecycle management, or emerging AI compliance frameworks preferred
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.
National (US) Range: $87,780 USD - $118,062 USD
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Show more Show less
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Job Overview: We are seeking a Lead CSV/CSA Engineer to support GxP compliance activities across Data Analytics, Artificial Intelligence (AI), Machine Learning (ML), and Digital platforms. This role will work closely with Quality, IT, Data Analytics, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations, internal procedures, and data integrity requirements.
Lead Validation Engineer Responsibilities:
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
Requirements:
5–8 years of hands-on experience supporting GxP systems, Data Analytics platforms, Artificial Intelligence solutions, or a combination of these domains
Hands-on experience supporting cloud-based, SaaS, COTS, or enterprise data platforms in regulated environments
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH), data integrity requirements, and ALCOA+ principles
Familiarity with AI, Machine Learning, advanced analytics, or business intelligence platforms
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality, IT, Data, and business stakeholders
Experience Machine Learning, Business Intelligence, Data Lake, Data Warehouse, or Digital Transformation platforms preferred
Experience with technologies such as Power BI, Tableau, Snowflake, Databricks, Azure, AWS, Google Cloud, or similar platforms preferred
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms preferred
Experience supporting AI governance, model lifecycle management, or emerging AI compliance frameworks preferred
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.
National (US) Range: $87,780 USD - $118,062 USD
Benefits
Why Choose Verista?
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
Show more Show less