GxP Lab Computer Engineer

4 weeks ago

waltham, United States firstPRO, Inc Full time

GxP Lab Computing Engineer

The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support team.

Requirements

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

Requirements Management

  • 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, Chemical
  • At least 5 years of directly relevant experience, including:
  • At least 3 years in software development and testing.
  • At least 2 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, 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

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