Über diese 6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer Stelle bei Verista, Inc.
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Senior CSA Analyst – Plasma Systems & Site Enablement Responsibilities:
Computer Software Assurance & Validation
- Lead CSA activities for plasma-related applications and systems supporting regulated donor operations and business processes.
- Develop and execute risk-based validation strategies aligned with CSA principles and industry best practices.
- Support validation planning, testing, execution, and release readiness for donor-facing and operational support applications, including personalized payment capabilities.
- Provide CSA oversight for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deployments.
- Support validation and compliance activities for medical device-related systems and applications.
Compliance & Risk Management
- Apply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations.
- Ensure validation activities align with applicable GxP requirements, quality standards, and regulatory expectations.
- Evaluate system changes, enhancements, and integrations to determine validation scope and testing requirements.
- Support deviation assessments, defect triage, change control activities, and documentation review processes.
System Implementation & Deployment Support
- Partner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategies.
- Support system implementation activities including:
- Configuration verification
- Integration testing
- User Acceptance Testing (UAT)
- Data migration and data flow assessments
- Release readiness evaluations
- Operational readiness activities
- Assist with cross-functional readiness efforts for systems entering regulated plasma operations environments.
Documentation & Quality Deliverables
- Author and/or review validation lifecycle documentation, including:
- Risk Assessments
- Validation Plans
- Requirements Specifications
- Test Strategies and Protocols
- Traceability Matrices
- Summary Reports
- Change Controls
- Ensure documentation is complete, compliant, and inspection-ready.
- Guide project teams on appropriate levels of testing rigor, evidence collection, and documentation based on system risk and business impact.
Requirements:
- Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related discipline.
- Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries.
- Strong understanding of:
- GxP computerized systems
- Risk-based validation methodologies
- CSA principles and practices
- Software development and implementation lifecycles
- Experience supporting regulated system implementations, enhancements, integrations, or change management activities.
- Demonstrated ability to assess system risk, define validation strategies, and drive deliverables through review and approval.
- Experience collaborating with Quality, IT, Operations, business stakeholders, and technical teams.
- Strong knowledge of:
- Requirements management
- Test planning and execution
- Traceability
- Deviation management
- Validation reporting
- Release readiness processes
- Ability to work independently and effectively across multiple concurrent project workstreams.
Preferred Qualifications
- Experience in plasma, blood products, biologics, pharmaceutical manufacturing, clinical operations, or medical device environments.
- Experience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platforms.
- Knowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applications.
- Experience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated data capture systems.
- Experience supporting:
- New site startups
- Facility readiness initiatives
- Innovation center buildouts
- Large-scale digital transformation programs
- Experience with:
- System integrations
- Data migration activities
- Interface testing
- Data flow assessments
- Reporting and downstream system impacts
- Familiarity with:
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Data Integrity requirements
- Risk-based assurance methodologies
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- 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
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
