6420 - Senior CSV Engineer / Senior Validation Engineer

United States·King of PrussiaRemotesenior

QA & TestingValidation Engineer

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Lead SAP validation strategy and CSA/CSV activities for SAP S/4HANA, ECC, and integrated GxP systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Annex 11

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

~1 min read

→Lead SAP validation strategy and CSA/CSV activities for SAP S/4HANA, ECC, and integrated GxP systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Annex 11 requirements
→Provide oversight and approval of validation lifecycle deliverables, including URS, risk assessments, validation plans, test protocols, traceability matrices, and validation summary reports
→Support SAP integrations with enterprise applications such as MES, LIMS, Veeva, TrackWise, and other regulated systems, ensuring data integrity and end-to-end process compliance
→Review change controls, impact assessments, system enhancements, and upgrades to maintain validated state and inspection readiness
→Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring alignment with SDLC and quality procedures
→Monitor validation KPIs, drive continuous improvement initiatives, and provide SME support during audits, inspections, and cross-functional project activities

Requirements

~2 min read

5+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance
Strong experience with SAP or enterprise platform validation in GxP environments
Proven ability to review/approve validation documentation and oversee testing governance
Experience working remotely with global stakeholders
Experience supporting S/4HANA upgrades or large enterprise transformation programs
Familiarity with ALCOA+ documentation principles and quality governance frameworks
Prior lead-level CSA/CSV role

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

$70,491—$118,062 USD

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