GxP Lab Computing Engineer

Position : GxP Lab Computing Engineer

Location : Chicago, IL (Onsite, 5 days / week)

Experience : 5+ years

Visa : Any visa except H1B & CPT

Overview

The GxP Lab Computing Engineer will deliver consulting, analytical, and technical services supporting laboratory computing environments. This includes multivendor instrument systems, IT infrastructure, and in-lab validation and compliance activities. The role requires both technical expertise and strong customer-facing skills to analyze lab needs, propose effective solutions, and ensure smooth day-to-day IT operations in a GxP environment.

Key Responsibilities

Requirements Management & Validation Support

Understand business problems and define project scope.

Gather and analyze user and system requirements.

Support validation and compliance activities (IOPQ).

Identify gaps and propose process improvements aligned with GxP standards.

IT Consulting

Evaluate lab computing environments for optimization and modernization.

Research and apply industry best practices and trends.

Assess and recommend vendor solutions, facilitate demos and proofs of concept.

Develop and implement process improvements aligned with business goals.

Customer Liaison

Act as the main interface between lab owners, vendors, and IT teams.

Coordinate service schedules, meetings, and maintenance activities.

Provide weekly and monthly progress updates and reports to stakeholders.

Participate in operational reviews and metrics reporting.

Onsite Lab IT Support

Provide technical support and troubleshooting for lab instrument-connected systems.

Implement and maintain Windows security policies.

Ensure compliance with corporate and client policies through audits and reporting.

Support field engineers and vendors with technical issues.

Manage validation and change control for new systems.

Maintain inventory of lab systems, software, and related assets.

Perform scheduled system preventive maintenance.

Required Qualifications

Bachelor's or Master's degree in Pharmaceutical, Biotechnology, Biomedical, or Chemical Engineering (or related field).

5+ years of directly relevant experience, including :

Minimum 3 years in software development and testing .

Minimum 2 years in business requirements analysis and gathering .

Proven analytical, communication, and interpersonal skills.

Demonstrated ability to design, implement, and validate lab systems.

Experience building client relationships and managing cross-functional projects.

Preferred Domain Expertise

Drug Discovery & Development Processes

Clinical Study Planning & Data Management

Laboratory Workflows

Chemical & Biologic Material Management

Sample Management

Robotic Systems Integration & Qualification

Operations KPI and Metrics Tracking

Regulatory Knowledge (Preferred)

Familiarity with US and International Regulations / Standards , including :

GLP , GMP , 21 CFR Part 11 , Part 210 , Part 211 , Part 820

Technical Skills

Operating Systems : Unix, Windows, or MVS

Programming Concepts : Object-Oriented and Structured Programming

Development Methodologies : Waterfall, Agile

Management Practices : Change Control, Risk Management

Office Tools : MS Word, Excel, PowerPoint

Productivity Tools : Visio, MS Project, or SharePoint