Validation Engineer

BCforward is seeking an experienced Validation Engineer to work hybrid in Indianapolis

Validation Engineer – GxP

Location: Indianapolis, IN – Downtown

Work Arrangement: Hybrid – Minimum 3 days onsite per week

Position Summary

This role focuses on application lifecycle management (ALM), validation readiness, change control, technical documentation, and release coordination for ongoing system enhancements.

The ideal candidate brings strong ALM expertise, pharmaceutical validation experience, excellent documentation skills, and the ability to proactively identify gaps, coordinate remediation, and support compliant, timely application releases.

Key Responsibilities

ALM & Requirements Traceability: Review requirements, test plans, test scripts, and Requirements Traceability Matrices (RTMs). Identify gaps in requirements coverage, testing, and validation documentation.

GxP Validation: Support computerized system validation (CSV), risk-based testing, and validation readiness in accordance with GxP/GMP requirements.

Change Control: Prepare and review ServiceNow change requests, ensuring completeness and readiness for Pre-CRB, CRB, and subsequent approval milestones.

Release Readiness: Collaborate with Product Managers, Scrum Masters, testing teams, and Quality Assurance to coordinate deliverables, resolve dependencies, and support release approvals.

Continuous Improvement: Identify opportunities to improve validation, documentation, and change management processes through AI, automation, and operational efficiencies.

Required Qualifications

Strong knowledge of Application Lifecycle Management (ALM), including requirements management, requirements-to-test traceability, test coverage analysis, and validation documentation.

Experience with GxP/GMP computerized system validation (CSV) in pharmaceutical, biotechnology, or regulated life sciences environments.

Experience with regulated change control processes, validation readiness, and formal approval workflows.

Strong analytical, technical documentation, and cross-functional communication skills.

Ability to work independently, proactively identify issues, and coordinate resolution across multiple stakeholders.

Preferred Qualifications

Experience with Veeva Vault Quality/QMS, Veeva QualityDocs, or similar regulated enterprise applications.

Familiarity with ServiceNow change management.

Experience with Jira, Agile/Scrum, and enterprise application release processes.

Familiarity with Lucid, AI-assisted documentation tools, and workflow automation.

Success Criteria

The successful candidate will ensure change requests, validation documentation, and technical deliverables are complete, accurate, and prepared for required approval milestones while proactively identifying risks and opportunities for continuous improvement.

Role Focus: Validation review, ALM traceability, change control preparation, and release readiness coordination rather than primary test script execution or formal quality approval.