Senior CSA Analyst – Plasma Systems / Senior Validation Engineer

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $78.9k - $118.1k / year

⏰ Full Time

🟠 Senior

🧐 Analyst

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏭 Manufacturing

🍽️ Food & Beverage

Consulting • Manufacturing • Food & Beverage

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

• Lead and execute CSA activities for computerized systems supporting Plasma operations • Support validation of system changes, enhancements, integrations, configurations, and releases • Assess system and change risk and define the appropriate CSA strategy, testing approach, and documentation level • Develop and/or review risk assessments, validation plans, requirements, test strategies, test scripts, traceability, summary reports, and change control documentation • Apply risk-based CSA principles based on intended use, process impact, donor impact, data integrity, and system criticality • Partner with IT, Quality, business process owners, technical teams, and other stakeholders throughout the system lifecycle • Support test execution, defect and deviation management, documentation review, and release readiness • Review system integrations, interfaces, data flows, and configuration changes • Ensure validation activities align with procedures, quality system requirements, and regulatory expectations • Provide practical CSA guidance to project teams and determine appropriate evidence and testing rigor based on risk • Independently manage assigned CSA activities and progress deliverables through review and approval according to project timelines

🎯 Requirements

• Senior-level CSV/CSA experience within life sciences, biotechnology, pharmaceutical, plasma, blood products, or another regulated environment • Strong understanding of GxP computerized systems, Computer Software Assurance, and risk-based validation principles • Experience supporting regulated application changes, enhancements, integrations, and releases • Ability to assess system risk and independently define and execute an appropriate validation strategy • Strong experience with requirements, risk assessments, test planning, test execution, traceability, deviation management, validation reporting, and release readiness • Experience working cross-functionally with IT, Quality, business process owners, and technical teams • Ability to operate independently within an established program and manage multiple concurrent validation activities • Preferred: Direct experience supporting Plasma or blood products systems and business processes • Preferred: Experience with donor management, donor operations, plasma collection, or related regulated processes • Preferred: Experience with system integrations, interfaces, data flows, master data, or reporting in a regulated environment • Preferred: Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity expectations, and risk-based assurance practices

🏖️ Benefits

• 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 • Employee Recognition • Employee Referral Program • Paid Parental Leave and Bereavement • High growth potential and people-focused culture