CSA Consultant – Senior Validation Engineer

🕒 il y a 2 jours

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $70 491 - $118 062 / an

⏰ Temps Plein

🟠 Senior

👷🏻‍♀️ Ingénieur

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Verista, Inc.

Site WebLinkedInTous les Emplois

501 - 1000 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• 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 • Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory compliance. • Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance. • Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation. • Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions. • Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement. • Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

🎯 Exigences

• 5–8 years of 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

🏖️ 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