Senior IT Lab Systems Delivery & Compliance Lead (Contract – 6+ Months)

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. The ideal candidate operates independently, executes with structure and rigor, and brings strong regulatory awareness.

You will partner closely with an assigned North America–based IT Lead while maintaining ownership of execution, documentation, and compliance outcomes.

Key Responsibilities

Delivery of New Local Laboratory Systems

• 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 (ServiceNow, governance workflows, etc.)

• Support system onboarding, access management, and operational readiness

Compliance Assessment of Existing Systems

• Assess HQ laboratory computerized systems against:

  • CSQ requirements

  • Validation lifecycle standards

  • IT security standards

  • Architecture/network compliance

• Identify gaps, risks, and remediation needs

• Document findings and support audit readiness activities

Validation & Remediation Execution

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

• ServiceNow Knowledge Article development

• IT Security administration procedures

• RTO documentation and Service Desk transition

• Monitoring verification and post-cutover impact review

Required Qualifications

• 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 (ServiceNow or similar)

• Familiarity with Information Security standards and infrastructure coordination

• Ability to operate independently with minimal oversight

• Strong documentation and stakeholder communication skills

Preferred:

• Experience in global pharmaceutical or life sciences organizations

• Governance or architecture board presentation experience

• Remediation or audit recovery program involvement

• Familiarity with Veeva workflows