Senior CSV Engineer / Senior Validation Engineer

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assist in the development of UAT scope, test scenarios, and test scripts based on approved requirements and business processes.

• Organize and support UAT execution, including tester scheduling, evidence collection, defect tracking, retesting, traceability, and closure.

• Create and update SOPs, work instructions, job aids, templates, commissioning documents, and revisions to global procedures.

• Ensure documents are formatted in accordance with client standards and adhere to Good Documentation Practices.

• Manage the routing of documents through the client’s electronic document management system and facilitate review and approval workflows.

• Aid in the digitization of document and template libraries, focusing on formatting, metadata, traceability fields, and document tracking.

• Create and format training materials, quick-reference guides, and user communications.

• Assist with change-control activities, adoption materials, and tracking implementation actions.

• Maintain deployment-readiness trackers that cover user access, training completion, readiness checklists, cutover inputs, and open actions.

• Support go-live and hypercare efforts, including logging issues, routing, follow-up, and tracking resolutions.

• Help prepare translation packages and coordinate reviews for content in Portuguese, Japanese, and Spanish.

• Collaborate with global C&Q representatives, subject matter experts, Quality, IT, site teams, and external vendors.

• Provide clear updates on progress, issues, risks, and actions.

⛳️ Requirements

• Bachelor's Degree in a relevant industry-related field.

• Over 5 years of experience supporting regulated life sciences systems, validation, quality, engineering, or digital transformation initiatives.

• Practical experience with UAT, test-script development, regulated documentation, or system deployment activities.

• Familiarity with GxP, CSV, CSA, validation, or practices related to regulated system implementation.

• Experience in authoring or revising SOPs, work instructions, test scripts, job aids, templates, or other controlled documentation.

• Knowledge of requirements traceability, test evidence, defect management, document workflows, or tracking deployment readiness.

• Strong writing, organizational, communication, and stakeholder coordination skills.

• Capability to manage multiple priorities and work independently within a global, cross-functional team.

• Preferred experience with digital C&Q, validation, quality, engineering, or manufacturing platforms.

• Preferred experience with Kneat or a comparable digital validation solution.

• Preferred familiarity 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 in supporting enterprise or multi-site deployments.

• Familiarity with change control, training-readiness tracking, go-live, and hypercare is preferred.

• Preferred experience in coordinating translation packages or multilingual document updates.

• This position is remote; limited travel to client sites may be required with prior notice.

🏝️ Benefits

• High growth potential in a fast-paced organization that emphasizes a people-focused culture.

• Competitive salary along with performance-based incentive programs.

• Company-paid Life, Short-Term, and Long-Term Disability Insurance.

• Comprehensive Medical, Dental & Vision insurance plans.

• Flexible Spending Account (FSA), DCARE, and Commuter Benefits.

• Supplemental Life, Hospital, Critical Illness, and Legal Insurance options.

• Health Savings Account availability.

• 401(k) Retirement Plan with Employer Matching benefits.

• Paid Time Off (with Rollover Option) and Holidays.

• Additional Sick Time as needed.

• Tuition Reimbursement program.

• Team Social Activities for a fun work environment!

• Employee Recognition initiatives.

• Employee Referral Program.

• Paid Parental Leave and Bereavement leave.