Transformative business, compliance, and technology solutions for the life sciences industry
Senior Validation Engineer
Location
Pennsylvania
Posted
3 days ago
Salary
$70.5K - $118.1K / year
Seniority
Senior
Job Description
Senior Validation Engineer
Verista, Inc.
• 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.
Job Requirements
- 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
- 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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