New

Senior IT CSV Lab Systems Delivery & Compliance Lead

TEKsystems
$35.00 - $55.00 / hr
life insurance, sick time, 401(k), retirement plan
United States, Indiana, Indianapolis
Mar 12, 2026
W2 ONLY, NO C2C HYBRID Schedule in Indianapolis, IN (2-days onsite/the rest remote) MUST LIVE IN INDIANAPOLIS, IN OR SURROUNDING SUBURBS to go onsite in DOWNTOWN INDY! Position Summary Our client is seeking a senior-level IT professional to lead the delivery of new local computerized laboratory systems and the compliance remediation of existing HQ laboratory systems. This role requires deep experience in regulated environments (GxP), IT validation, security, infrastructure coordination, and cross-functional stakeholder engagement. The selected candidate will operate with minimal supervision and will partner closely with an assigned Lead who will oversee day-to-day alignment. The expectation is independent execution, structured documentation, and strong regulatory awareness. ________________________________________ Scope of Work 1. Delivery of New Local Computerized Laboratory Systems Deploy and configure local laboratory systems including: oLaboratory instruments and associated software oWorkstations and servers oInterfaces and network components Ensure alignment with: oIT architecture standards oInformation Security requirements oComputer Systems Quality (CSQ) validation standards Coordinate infrastructure provisioning (hardware, hosting, networking) Support system onboarding, access management, and operational readiness Execute structured change management processes including: oVeeva business change workflows oServiceNow release/change management oCharter creation and governance approvals oSARB presentation (if required) ________________________________________ 2. Compliance Assessment of Existing Systems Assess HQ laboratory computerized systems against: oComputer Systems Quality (CSQ) requirements oValidation lifecycle standards oIT Security standards oIT architecture/network compliance Identify compliance gaps and risks Document findings and remediation requirements Support audit readiness activities ________________________________________ 3. Validation & Remediation Execution Lead or support the following validation lifecycle activities: Validation Risk Assessment (VRA) Validation Plan development Requirements / Design / Functional Specifications DRP / BCP documentation Security Plan documentation IQ/OQ protocol approval, execution, and reporting PQ protocol approval, execution, and reporting IT requirements testing (if not executed elsewhere) Validation Summary Report Additional responsibilities include: Creation of IT CAPAs (Periodic Review, ARR, Audit Trail Review) Creation/update of ServiceNow Knowledge Articles IT Security Administration Procedures RTO and Service Desk handover Technical Operations RACI alignment (if required) Verification of monitoring enablement Post-cutover IT funding impact review Additional Skills & Qualifications* Deliverables System delivery & configuration documentation (new systems) Compliance assessment report (existing systems) Prioritized remediation plan Remediation execution evidence Validation documentation package Final compliance summary report ________________________________________ Required Qualifications 8+ years 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, interfaces, middleware) Hands-on experience with: oIQ/OQ/PQ execution oValidation documentation authoring oIT change management (ServiceNow or similar) Familiarity with: oInformation Security standards oInfrastructure coordination (servers, networking, hosting) oCAPA processes Ability to operate independently with minimal oversight Strong documentation and stakeholder communication skills ________________________________________ Preferred Qualifications Experience working in global pharmaceutical or life sciences organizations Experience presenting to governance boards (e.g., architecture review boards) Prior involvement in remediation or audit recovery programs Familiarity with Veeva workflows and regulated IT environments Job Type & LocationThis is a Contract position based out of Indianapolis, IN. Pay and BenefitsThe pay range for this position is $35.00 - $55.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace TypeThis is a hybrid position in Indianapolis,IN. Application DeadlineThis position is anticipated to close on Mar 23, 2026. h4>About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.