Senior CSV Engineer - Kneat Implementation

QvalFocus Inc.; Indianapolis (IN); Hybrid; USD 110,000 - 150,000; Full time

Job summary

QvalFocus Inc. in Indianapolis, IN and Massachusetts offers a hybrid Senior CSV Engineer role to support a Kneat implementation in a regulated life sciences environment. You will lead UAT scenarios, validate documentation, and ensure deployment readiness while maintaining controlled documents.

Collaborating with Quality, IT, Engineering, C&Q, site teams, SMEs, and vendors, you will ensure traceability, testing progress, and multilingual documentation as needed.

Qualifications

• 5+ years in CSV, validation, quality, engineering, or regulated life sciences environments.
• Hands-on experience with UAT, test scripts, validation documentation, or system implementation.
• Knowledge of GxP, CSV, CSA, or regulated computerized systems.
• Experience with SOPs, work instructions, test documentation, or controlled documents.
• Strong organizational, writing, communication, and stakeholder-management skills.

Responsibilities

• Develop UAT scenarios, test scripts, and supporting test documentation.
• Coordinate UAT execution, evidence collection, defects, retesting, and traceability.
• Create and update SOPs, work instructions, job aids, templates, and validation documents.
• Manage controlled documents through electronic document management workflows.
• Support requirements traceability, document tracking, and deployment readiness.
• Develop training materials and user communications.
• Support change control, go-live, and hypercare activities.
• Track user access, training completion, open actions, and implementation readiness.
• Coordinate with Quality, IT, Engineering, C&Q, site teams, SMEs, and vendors.
• Support multilingual document and translation activities as needed.

Skills

UAT testing

Validation documentation

Documentation & SOPs

Stakeholder coordination

Scientific/regulated env experience

Tools

Kneat

HP ALM/Quality Center

Jira

Veeva Vault

Documentum

BMSDocs

Job description

Senior CSV Engineer Kneat Implementation

Locations: Massachusetts / Indianapolis, IN

Work Model: Hybrid

Position Summary

Seeking a Senior CSV Engineer to support a Kneat implementation within a regulated life sciences environment. The role will focus on UAT, validation documentation, deployment readiness, controlled documents, and cross-functional coordination.

Key Responsibilities

• Develop UAT scenarios, test scripts, and supporting test documentation.
• Coordinate UAT execution, evidence collection, defects, retesting, and traceability.
• Create and update SOPs, work instructions, job aids, templates, and validation documents.
• Manage controlled documents through electronic document management workflows.
• Support requirements traceability, document tracking, and deployment readiness.
• Develop training materials and user communications.
• Support change control, go-live, and hypercare activities.
• Track user access, training completion, open actions, and implementation readiness.
• Coordinate with Quality, IT, Engineering, C&Q, site teams, SMEs, and vendors.
• Support multilingual document and translation activities as needed.

Required Qualifications

• 5+ years of experience in CSV, validation, quality, engineering, or regulated life sciences environments.
• Hands-on experience with UAT, test scripts, validation documentation, or system implementation.
• Knowledge of GxP, CSV, CSA, or regulated computerized systems.
• Experience with SOPs, work instructions, test documentation, or controlled documents.
• Strong organizational, writing, communication, and stakeholder-management skills.

Preferred Skills

• Kneat or similar digital validation platforms.
• HP ALM/Quality Center, Jira, or similar test-management tools.
• Veeva Vault, Documentum, BMSDocs, or similar document-management systems.
• Experience with enterprise or multi-site implementations.
• Experience with change control, training readiness, go-live, and hypercare.
• Experience supporting multilingual documentation.