6276 - CSV QA Specialist / Sr. Validation Engineer

Verista, Inc. • Somerset, NJ

16h

About The Position

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.
The CSV QA Specialist is responsible for the review and approval of Computer System Validation (CSV) deliverables to ensure compliance with GxP, regulatory requirements, and data integrity standards. This role provides quality oversight for ERP Master Data Governance and Data Lake platforms, ensuring validation activities are executed in accordance with established SDLC and validation frameworks.

Requirements

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related discipline
• 5+ years of QA or CSV experience within pharmaceutical or life sciences environments
• Strong experience reviewing and approving CSV/SDLC deliverables for GxP systems
• Experience with Master Data Governance processes (SAP experience preferred but not required)
• Experience reviewing validation for Data Lake environments and system interfaces (Snowflake experience preferred)
• Strong knowledge of GxP, 21 CFR Part 11, data integrity, and SDLC methodologies
• Ability to work independently, provide QA oversight, and make risk-based quality decisions

Nice To Haves

• Familiarity with AI/data platforms is a plus
• Experience with electronic validation systems such as ValGenesis is a plus

Responsibilities

• Perform QA review and approval of CSV lifecycle documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports
• Ensure all validation deliverables comply with GxP, 21 CFR Part 11, and internal quality standards
• Provide quality oversight for ERP Master Data Governance processes, ensuring data integrity and proper control of master data elements
• Review validation activities for Data Lake platforms and system interfaces, including data ingestion, transformation, and reporting workflows
• Partner with IT, Validation, Data Engineering, and Business teams to ensure SDLC and validation requirements are clearly defined and met
• Support deviation, CAPA, and change control review and approval related to validated systems
• Identify compliance gaps and drive continuous improvement in validation and documentation practices

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees