6139 - Computer System Assurance (CSA) Consultant / Senior Validation Engineer

Verista; King of Prussia (PA); On-site; USD 84,465 - 113,500; Full time

Benefits offered by this job

High growth potential

Competitive pay plus incentives

Medical, Dental & Vision insurances

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Team Social Activities

Job summary

A leading life sciences consulting firm is seeking an experienced Computer System Assurance Consultant in King of Prussia, PA. The role focuses on supporting GxP compliance across relevant systems. Responsibilities include providing expertise on validation and compliance, overseeing system implementations, and ensuring adherence to regulatory requirements. Candidates should have 5-8 years of relevant experience, strong knowledge of CSA principles, and the ability to thrive in a fast-paced environment. Competitive salary range is $84,465 - $113,500.

Qualifications

• 5–8 years of hands-on experience in GxP systems.
• Understanding of CSA principles and CSV processes.
• Knowledge of GxP regulations and data integrity expectations.

Responsibilities

• Provide CSA / CSV expertise across various platforms.
• Support system implementations and compliance activities.
• Develop and review validation deliverables and documentation.

Skills

GxP compliance

Validation documentation

Strong communication skills

Regulatory knowledge (FDA, EMA, ICH)

Job description

Overview

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

Role

We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.

Key Responsibilities

• 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

Requirements

• 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
• 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

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.

National (US) Range: $84,465 USD - $113,500 USD

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

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For more information about our company, please visit us at Verista.com