**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 withanizations, 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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseSenior Validation Engineer 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 requirementsProvide oversight and approval of validation lifecycle deliverables, including URS, risk assessments, validation plans, test protocols, traceability matrices, and validation summary reportsSupport SAP integrations with enterprise applications such as MES, LIMS, Veeva, TrackWise, and other regulated systems, ensuring data integrity and end-to-end process complianceReview change controls, impact assessments, system enhancements, and upgrades to maintain validated state and inspection readinessGuide testing readiness activities, CMDB governance, and validation tool utilization while ensuring alignment with SDLC and quality proceduresMonitor validation KPIs, drive continuous improvement initiatives, and provide SME support during audits, inspections, and cross-functional project activitiesJob Requirements:5+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciencesDemonstrated leadership of validation strategy, lifecycle deliverables, and SDLC complianceStrong experience with SAP or enterprise platform validation in GxP environmentsProven ability to review/approve validation documentation and oversee testing governanceExperience working remotely with global stakeholdersExperience supporting S/4HANA upgrades or large enterprise transformation programsFamiliarity with ALCOA+ documentation principles and quality governance frameworksPrior lead-level CSA/CSV roleBenefitsWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at
Verista.com
2 months ago