6375 - Data Analytics/AI Validation Engineer / Lead Validation Engineer

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—$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

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For more information about our company, please visit us at Verista.com