Senior CSV Engineer / Senior Validation Engineer

🕒 Agosto 24

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $78.925 - $113.521 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

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Verista, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

💼 Consultoria

🏭 Manufatura

🍽️ Alimentos e Bebidas

Consulting • Manufacturing • Food & Beverage

A Verista, Inc. é uma provedora de serviços especializada em soluções para os setores de ciências biológicas, biotecnologia, farmacêutico e dispositivos médicos. Eles oferecem expertise em áreas como comissionamento, qualificação e validação, integração de visão e sistemas, soluções tecnológicas, análise e estratégia de dados, cibersegurança, transformação digital, conformidade regulatória e gestão de infraestrutura. A Verista se destaca na prestação de serviços gerenciados, gestão de programas e projetos, e estratégia digital para garantir qualidade e conformidade ao longo do ciclo de vida do produto. Seu foco em engajamento personalizado e comunicação eficaz faz deles um parceiro preferido entre as principais empresas de ciências biológicas em todo o mundo.

Descrição

• Support development of UAT scope, test scenarios, and test scripts based on approved requirements and business processes • Coordinate and support UAT execution, tester scheduling, evidence collection, defect tracking, retesting, traceability, and closure • Draft and update SOPs, work instructions, job aids, templates, commissioning documents, and global procedure revisions • Format documents according to client standards and Good Documentation Practices • Route documents through the client’s electronic document management system and support review and approval workflows • Support digitization of document and template libraries, including formatting, metadata, traceability fields, and document tracking • Develop and format training materials, quick-reference content, and user communications • Support change-control activities, adoption materials, and implementation action tracking • Maintain deployment-readiness trackers covering user access, training completion, readiness checklists, cutover inputs, and open actions • Support go-live and hypercare activities, including issue logging, routing, follow-up, and resolution tracking • Assist with translation-package preparation and review coordination for Portuguese, Japanese, and Spanish content • Coordinate with global C&Q representatives, subject matter experts, Quality, IT, site teams, and external vendors • Provide clear progress, issue, risk, and action updates

🎯 Requisitos

• Bachelors Degree in industry-related discipline • 5+ years of experience supporting regulated life sciences systems, validation, quality, engineering, or digital transformation projects • Hands-on experience with UAT, test-script development, regulated documentation, or system deployment activities • Working knowledge of GxP, CSV, CSA, validation, or regulated system implementation practices • Experience authoring or revising SOPs, work instructions, test scripts, job aids, templates, or other controlled documentation • Familiarity with requirements traceability, test evidence, defect management, document workflows, or deployment-readiness tracking • Strong writing, organization, communication, and stakeholder-coordination skills • Ability to manage multiple priorities and work independently within a global, cross-functional team • Experience with digital C&Q, validation, quality, engineering, or manufacturing platforms preferred • Experience with Kneat or a comparable digital validation solution preferred • Experience with HP ALM/Quality Center, Jira, or another test-management platform preferred • Experience with BMSDocs, Documentum, Veeva Vault, or another electronic document management system preferred • Experience supporting enterprise or multi-site deployments preferred • Familiarity with change control, training-readiness tracking, go-live, and hypercare preferred • Experience coordinating translation packages or multilingual document updates preferred • This role is remote; limited travel to client site may be requested with advance notice

🏖️ Benefícios

• 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