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