GxP Lab Computing Engineer

Zifo · North Chicago, IL · 1 mo ago

On-siteInformation TechnologyFull-time

This role requires 100% on-site presence at the client in North Chicago, IL. Relocation assistance is not available.

About the role

The Zifo Lab Computing Engineer delivers consulting, analytical, and technical laboratory services, including multivendor instrument and information technology support, as well as in-lab validation and compliance services where applicable. The role involves analyzing customer needs and gaps to propose solutions, collaborating with business users and managers, and working alongside Zifo’s internal support team.

Responsibilities

Requirements Management and Onsite Validation/Compliance Support
- Understand problem statements and challenges
- Define scope and gather requirements
- Assist with validation/compliance activities (IOPQ) as required
- Analyze current-state business processes and requirements
- Assist in building plans for process improvement
IT Consulting
- Analyze gaps and opportunities for improvement based on industry best practices
- Evaluate industry trends to identify optimization areas
- Evaluate vendor solutions and facilitate prototype demonstrations as proofs of concept
- Recommend process improvements aligned with business needs
Customer Liaison
- Meet with internal/external service groups and leads
- Coordinate schedules with system/lab owners and third parties
- Provide weekly planning schedules for customer lead reviews
- Participate in monthly operational reviews and quarterly metrics reporting with department heads
Onsite Lab IT Support
- Perform break/fix support for all instrument-connected systems
- Implement Windows-based security policies as required
- Ensure adherence to client corporate policies via periodic reporting and compliance programs
- Act as technical support contact for field service engineers and external vendors
- Provide technical subject matter expertise for new system validation and change management
- Create and maintain a physical inventory of lab equipment, PCs, software, and other relevant information
- Perform system preventative maintenance based on client schedule, where applicable

Requirements

Bachelor’s or Master’s degree (or equivalent) in Pharmaceutical, Biotechnology, Biomedical, or Chemical discipline
5+ years of relevant technical experience, including:
- Windows technologies
- Networking
- Remote computing
- Backup systems
At least 3 years in software development and testing
At least 2 years of experience in business requirements analysis and gathering
Demonstrated domain knowledge in one or more of the following areas:
- Drug discovery and development processes
- Clinical study planning and data management
- Lab workflows
- Chemical and biologics material management
- Sample management
- Robotic systems integration and qualification
- Operations KPI and metrics tracking
Familiarity with US and international regulations and standards (e.g., GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820) is a plus
Excellent analytical and interpersonal skills
Proven track record in system design and implementation
Ability to guide colleagues and gain client confidence and trust
Knowledge of laboratory safety practices per company and/or customer site safety codes

Technical Skills

Operating Systems: Unix, Windows, or MVS
Software Methodologies: Object-Oriented Programming, Structured Programming
Software Development Processes: Waterfall, Agile
Office Tools: MS Word, Excel, PowerPoint
Office Productivity Tools: Visio, MS Project, or SharePoint

Benefits