Senior CSV Engineer / Senior Validation Engineer

🕒 il y a 1 mois

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $70 491 - $118 062 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

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Verista, Inc.

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501 - 1000 employés

💼 Conseil

🏭 Fabrication

🍽️ Alimentation et boissons

Consulting • Manufacturing • Food & Beverage

Verista, Inc. est un prestataire de services spécialisé dans les solutions pour les secteurs des sciences de la vie, de la biotechnologie, de l'industrie pharmaceutique et des dispositifs médicaux. Ils offrent leur expertise dans des domaines tels que la mise en service, la qualification et la validation, l'intégration de systèmes et de vision, les solutions technologiques, les analyses de données et la stratégie, la cybersécurité, la transformation numérique, la conformité réglementaire et la gestion des infrastructures. Verista excelle dans la fourniture de services gérés, de gestion de programmes et de projets, et de stratégie numérique pour assurer la qualité et la conformité tout au long du cycle de vie des produits. Leur focus sur l'engagement personnalisé et la communication efficace en fait un partenaire privilégié parmi les plus grandes entreprises des sciences de la vie à travers le monde.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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