GxP Lab Computing Analyst

About the role

This position requires full-time on-site presence at our client site in North Chicago, IL. This position is not eligible for relocation assistance.

Responsibilities

• Requirements Management and onsite Validation/Compliance support
  • Understand problem statement/challenges
  • Define scope
  • 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/opportunities for improvement based on industry Best Practice
  • Evaluate industry trends to identify areas for optimization
  • Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept
  • Recommend process improvements that fit business needs
• Customer Liaison
  • Meeting with internal/external service groups/leads
  • Liaise between System/Lab owners and third parties to coordinate best times for services
  • Provide weekly planning schedules for review at status meeting with customer leads
  • Monthly Operational review meetings/Quarterly metrics reporting with department heads
• On Site Lab IT Support
  • Perform break/fix support for all Instrument connected systems
  • Implement Windows based security policies as required
  • Ensure adherence to client's corporate policies through periodic reporting & compliance programs
  • Acts as the 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, PC's, software, and any other information pertinent to the environment if applicable
  • Perform system preventative maintenances based on client's schedule, if applicable

Requirements

• Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical engineering, Chemical engineering
• At least 3 years of directly relevant Information Technology experience, including:
  • At least 1 year in software development and testing
  • At least 1 year of experience in business requirement analysis and gathering
• Demonstrated domain area knowledge
• Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design and implementation
• Candidate must have demonstrated ability to guide the activities of colleagues and gain client's confidence and trust
• Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:
  • Drug Discovery & Development Processes
  • Clinical study planning & Data management
  • Lab Workflows
  • Chemical & Biologics material Management
  • Sample Management
  • Robotic Systems Integration & Qualification
  • Operations KPI and Metrics tracking
• Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820

Technical Skills

• Operating System familiarity with at least 1 of the following: Unix, Windows, MVS
• Software Methodology familiarity with: Object Oriented Programming, Structured Programming
• Software Development Process familiarity with: Waterfall, Agile
• Change Control Management and Risk Management
• Office Tools proficiency required in: MS Word, Excel, PowerPoint
• Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint

Benefits

• Competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts