Senior IT Validation & Laboratory Systems Lead

We are seeking a Senior IT Validation & Laboratory Systems Lead to drive deployment of new laboratory computerized systems and lead compliance remediation of existing HQ laboratory systems within a regulated GxP environment. This role requires advanced expertise in Computerized System Validation (CSV/CSQ), IT infrastructure, information security, and regulatory compliance. The selected candidate will operate with minimal supervision, ensuring structured execution, high-quality documentation, and alignment with enterprise IT governance and quality standards. The position will collaborate closely with a North America-based IT Lead who will provide oversight and governance alignment., 1. Deployment of New Laboratory Computerized Systems

• Deploy, configure, and implement laboratory instruments and associated software, workstations, servers, interfaces, and network components.

• Ensure compliance with enterprise IT architecture standards, information security policies, and CSQ validation requirements.

• Coordinate infrastructure provisioning including hardware, hosting, and networking.

• Support system onboarding, user access management, and operational readiness activities.

• Execute structured change management processes, including:

• Veeva change workflows

• ServiceNow change and release management

• Project charter development and governance approvals

• System Architecture Review Board (SARB) presentations, as required

2. Compliance Assessment of Existing Laboratory Systems

• Evaluate HQ laboratory systems against CSQ validation lifecycle standards, IT security controls, and data integrity requirements.
• Assess IT architecture and network compliance.
• Identify compliance gaps, risks, and deficiencies.
• Document findings and recommend risk-based remediation strategies.
• Support audit readiness and regulatory inspection activities.

3. Validation & Remediation Execution

• Lead and/or support full validation lifecycle activities, including:

• Validation Risk Assessments (VRA)

• Validation Plan development

• User Requirements, Functional, and Design Specifications

• Disaster Recovery (DRP) and Business Continuity (BCP) documentation

• Security Plan development

• IQ/OQ protocol development, execution, and reporting

• PQ protocol execution and reporting

• IT requirements testing

• Validation Summary Reports (VSR)

• Develop and manage IT CAPAs, including Periodic Reviews, Annual Review Reports (ARR), and Audit Trail Reviews.

• Create and maintain ServiceNow Knowledge Articles.

• Develop IT Security Administration procedures.

• Support Recovery Time Objective (RTO) definition and Service Desk transition activities.

• Align Technical Operations RACI matrices as needed.

• Ensure monitoring enablement and system health tracking.

• Conduct post-go-live funding assessments and impact evaluations.

Deliverables

• System deployment and configuration documentation
• Compliance assessment reports
• Risk-based remediation plans
• Complete validation documentation packages (IQ/OQ/PQ, VSR, etc.)
• Remediation execution evidence
• Final compliance summary reports, Description We are seeking a Senior Transmission Line Engineer who will work as a member of a dynamic team working in a fast paced environment, solving challenging problems invol…

• 8+ years of experience in regulated IT environments (pharmaceutical, biotechnology, or medical device industries).
• Strong expertise in GxP Computerized System Validation (CSV/CSQ).
• Experience supporting laboratory systems, including instruments, middleware, and system interfaces.
• Hands-on experience with IQ/OQ/PQ execution and validation documentation authoring.
• Experience with IT change management tools such as ServiceNow.
• Solid understanding of information security frameworks and IT infrastructure (servers, networking, hosting environments).
• Experience managing CAPA activities within quality systems.
• Proven ability to work independently with minimal supervision.
• Strong documentation, communication, and stakeholder management skills., * Experience within global pharmaceutical or life sciences organizations.
• Experience presenting to governance boards such as SARB or ARB.
• Prior involvement in audit remediation or compliance recovery initiatives.
• Familiarity with Veeva Vault workflows.
• Experience supporting regulated IT transformation or enterprise system deployment programs.