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GxP Lab Computing Engineer
GxP Lab Computing EngineerKatalyst HealthCares & Life Sciences • Chicago, IL
GxP Lab Computing Engineer

GxP Lab Computing Engineer

Katalyst HealthCares & Life Sciences • Chicago, IL
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Required Skills :

  • Excellent customer service skills complemented by an ability to listen to and interpret client requests
  • Ability to troubleshoot complex instrument and technology issues
  • Strong oral and written communication skills
  • Ability to identify, track and complete tasks for multiple projects
  • Knowledge of laboratory safety practices as defined by the company and / or customer's site safety code

Responsibilities :

As a Lab Computing Analyst, beneficiary would perform following key responsibilities :

  • Requirements Management and onsite Validation / Compliance support
  • IT Consulting
  • Customer Liaison
  • Onsite Lab IT 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
  • 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
  • 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, Chemical
  • At least years of directly relevant experience, including :
  • At least years in software development and testing.
  • At least years 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, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to 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
  • Optional requirement : Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, CFR Part , Part , Part , Part
  • Technical Skills :
  • Operating System familiarity with at least 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 of the following : Visio, MS Project, SharePoint
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