Verista, Inc.
6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer
King of Prussia, PA · Senior
Sponsorship not specified$70k-$118kDetected 35 days ago
About the role
- 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 talented and dedicated professionals are committed to making an impact every day.
- 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.
Responsibilities
- 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.
- Support deviation assessments, defect triage, change control activities, and documentation review processes.
- Partner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategies.
- System Implementation & Deployment Support
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:
- Strong knowledge of:
- Ability to work independently and effectively across multiple concurrent project workstreams.
Nice to have
- 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:
- New site startups
- Facility readiness initiatives
- Innovation center buildouts
- Large-scale digital transformation programs
- Experience with:
Compensation
- 21 CFR Part 11
- Data Integrity requirements
- Risk-based assurance methodologies
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
- Support validation and compliance activities for medical device-related systems and applications.
Company info
- 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
Apply directly at Verista, Inc. →Create a free account for alerts like thisView Verista, Inc. immigration profile
This listing is sourced directly from Verista, Inc.'s careers page and normalized into a canonical job model.