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6400- CSA Consultant / Senior Validation Engineer

2 hours, 29 minutes ago
United States
Full-time
Senior
Consultant
Quality Assurance and Testing
Apply Now
Verista

Verista

Verista provides transformative compliance, automation, validation, and packaging solutions for the life sciences, pharmaceutical, and manufacturing industries, ensuring consistent, safe, and high-quality results every time.

Pharmaceuticals
251-1K
Founded 2020
View All Jobs 5

Description

  • Provide CSA/CSV subject matter expertise across Pharmacovigilance, 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 such as URS, specifications, test plans, and test summaries in alignment with ALCOA+ and Good Documentation Practices.
  • Oversee validation readiness and ensure prerequisites are met before formal testing begins.
  • Support change control, configuration management, and release activities.
  • Partner with Quality, System Owners, and Business Process Owners to maintain ongoing compliance.
  • Provide guidance on CSA-based, risk-driven validation approaches.
  • Conduct periodic compliance reviews, validation health checks, and lifecycle assessments to maintain a validated state and regulatory compliance.
  • Support periodic review activities such as user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
  • Assess the compliance impact of deviations, incidents, CAPAs, and system issues, and ensure remediation and documentation are completed.
  • Review vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
  • Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process improvement opportunities.
  • Participate in governance forums and compliance review boards, providing CSA guidance for lifecycle management and operational support.

Requirements

  • 5–8 years of 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 such as FDA, EMA, and ICH, plus data integrity expectations.
  • Ability to work independently in a fast-paced, matrixed environment.
  • Strong communication skills and comfort interacting with Quality and business stakeholders.
  • Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations is preferred.
  • Prior experience as a Validation SME, CSA Lead, or Compliance Consultant is preferred.
  • Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms is preferred.

Benefits

  • Competitive pay with a national US salary range of $70,491–$118,062 USD.
  • Performance-based incentive programs.
  • Company-paid Life, Short-Term Disability, and Long-Term Disability insurance.
  • Medical, Dental, and Vision insurance.
  • Health Savings Account, FSA, DCARE, and commuter benefits.
  • 401(k) retirement plan with employer matching.
  • Paid Time Off with rollover option, paid holidays, and as-needed sick time.
  • Tuition reimbursement, paid parental leave, and bereavement leave.

Interested in this position?

Apply directly on the company website

Apply Now

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