Verista · 14 hours ago
6139 - Computer System Assurance (CSA) Consultant / Senior Validation Engineer
King of Prussia, PA
Full-time
Onsite
Mid, Senior Level
$84K/yr - $114K/yr
5+ years expVerista is a leading company in the life science industry, seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities. The role involves working closely with Quality, IT, and business stakeholders to ensure systems are compliant with regulations and internal procedures while providing CSA/CSV expertise across various platforms.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
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
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase