6420 - Senior CSV Engineer / Senior Validation Engineer
About The Position
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
Requirements
- 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
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 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
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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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
