Senior CSV Engineer / Senior Validation Engineer

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $78.9k - $113.5k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏭 Manufacturing

🍽️ Food & Beverage

Consulting • Manufacturing • Food & Beverage

Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ 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