CSA Consultant – Senior Validation Engineer

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $70.5k - $118.1k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.

📋 Description

• 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

• 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 (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