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:
o Laboratory instruments and associated software
o Workstations and servers
o Interfaces and network components
Ensure alignment with:
o IT architecture standards
o Information Security requirements
o Computer 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:
o Veeva business change workflows
o ServiceNow release/change management
o Charter creation and governance approvals
o SARB presentation (if required)
2. Compliance Assessment of Existing Systems
Assess HQ laboratory computerized systems against:
o Computer Systems Quality (CSQ) requirements
o Validation lifecycle standards
o IT Security standards
o IT 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:
o IQ/OQ/PQ execution
o Validation documentation authoring
o IT change management (ServiceNow or similar)
Familiarity with:
o Information Security standards
o Infrastructure coordination (servers, networking, hosting)
o CAPA 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 & Location
This is a Contract position based out of Indianapolis, IN.
Pay and Benefits
The 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 Type
This is a hybrid position in Indianapolis,IN.
Application Deadline
This position is anticipated to close on Mar 23, 2026.
>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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 101054TS
- Position Id: JP-005879982
- Posted 7 hours ago
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