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
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
