Senior Validation Engineer

Verista, Inc.

Computer System Assurance Consultant supporting GxP compliance activities in Pharmacovigilance, Clinical, and Regulatory Affairs. Collaborating with Quality, IT, and business stakeholders for compliance.

Posted 6/18/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesSenior💰 $70,491 - $118,062 per yearWebsite

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
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) and data integrity expectations
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality and business stakeholders.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxP systemsCSVSDLC processesvalidation documentationrisk assessmentstraceability matricesvalidation plansdata migrationschange controlconfiguration management

Soft Skills

strong communication skillsindependent workability to work in fast-paced environmentinterpersonal skillscollaborationguidanceprocess improvement