Senior IT Lab Systems Delivery & Compliance Lead

Location:

Indianapolis, IN (Hybrid / Onsite as needed)

Engagement:
Contract (6+ Months, Extension Possible)

A global life sciences organization is seeking a senior-level IT professional to lead the delivery of new local computerized laboratory systems and oversee compliance remediation efforts for existing HQ laboratory systems. This role requires deep expertise in regulated GxP environments, computerized system validation (CSV), IT security, and infrastructure coordination.

• Deploy and configure laboratory instruments, associated software, workstations, and servers
• Coordinate infrastructure provisioning (hardware, hosting, networking)
• Ensure alignment with IT architecture and Information Security requirements
• Drive Computer Systems Quality (CSQ) validation standards compliance
• Execute structured change management processes (Service Now, governance workflows, etc.)
• Support system onboarding, access management, and operational readiness

• Assess HQ laboratory computerized systems against:
• CSQ requirements
• Validation lifecycle standards
• IT security standards
• Identify gaps, risks, and remediation needs
• Document findings and support audit readiness activities

Lead or support full validation lifecycle activities including:

• Validation Risk Assessments (VRA)
• Validation Plans
• Requirements, Design, and Functional Specifications
• IQ/OQ/PQ protocol development, execution, and reporting
• Security and Disaster Recovery documentation
• Validation Summary Reports

Additional responsibilities include:

• Creation of IT CAPAs and remediation documentation
• IT Security administration procedures
• RTO documentation and Service Desk transition
• Monitoring verification and post-cutover impact review

• 8+ years of experience in regulated IT environments (pharma, biotech, medical device, or similar)
• Strong knowledge of GxP computerized system validation lifecycle
• Experience with laboratory computerized systems (instruments, middleware, interfaces)
• Hands‑on IQ/OQ/PQ execution and validation documentation authoring
• Experience with IT change management tools (Service Now or similar)
• Familiarity with Information Security standards and infrastructure coordination
• Ability to operate independently with minimal oversight
• Strong documentation and stakeholder communication skills