Senior CSA Analyst – Plasma Systems / Senior Validation Engineer

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Lead and implement CSA activities for computerized systems that facilitate Plasma operations.

• Assist in the validation of system modifications, enhancements, integrations, configurations, and releases.

• Evaluate system and change risks, and establish the appropriate CSA strategy, testing methods, and documentation standards.

• Create and/or review risk assessments, validation plans, requirements, test strategies, test scripts, traceability, summary reports, and change control documentation.

• Employ risk-based CSA principles considering intended use, process impact, donor impact, data integrity, and system criticality.

• Collaborate 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.

• Examine system integrations, interfaces, data flows, and configuration changes.

• Ensure validation activities are in accordance with procedures, quality system requirements, and regulatory expectations.

• Offer practical CSA guidance to project teams and identify suitable evidence and testing rigor based on risk.

• Independently oversee assigned CSA activities and push deliverables through review and approval in line with project timelines.

⛳️ Requirements

• Senior-level CSV/CSA experience in life sciences, biotechnology, pharmaceuticals, plasma, blood products, or another regulated environment.

• In-depth understanding of GxP computerized systems, Computer Software Assurance, and risk-based validation principles.

• Experience in supporting regulated application modifications, enhancements, integrations, and releases.

• Capability to assess system risk and autonomously define and execute an appropriate validation strategy.

• Extensive experience with requirements, risk assessments, test planning, test execution, traceability, deviation management, validation reporting, and release readiness.

• Experience collaborating cross-functionally with IT, Quality, business process owners, and technical teams.

• Ability to work independently within an established program and manage multiple concurrent validation activities.

• Preferred: Direct experience with Plasma or blood product systems and related business processes.

• Preferred: Experience in donor management, donor operations, plasma collection, or similar 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 salary along with performance-based incentive programs.

• Company-covered Life, Short-Term, and Long-Term Disability Insurance.

• Medical, Dental & Vision insurance plans.

• Flexible Spending Account (FSA), Dependent Care Assistance Reimbursement (DCARE), and Commuter Benefits.

• Supplemental Life, Hospital, Critical Illness, and Legal Insurance options.

• Health Savings Account availability.

• 401(k) Retirement Plan with employer matching benefits.

• Paid Time Off (with a rollover option) and holidays.

• Sick leave as needed.

• Tuition Reimbursement program.

• Team social activities to foster collaboration.

• Employee recognition initiatives.

• Employee referral program incentives.

• Paid parental leave and bereavement support.

• High growth potential within a people-focused culture.