What are the responsibilities and job description for the GxP Lab Computing Engineer position at ATA ANALYTIQ LLC?
Job Details
GxP Lab Computing Engineer
Location: Chicago, IL (onsite)
Must come from an extensive BioTech/Pharma background w/ good experience in GxP.
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
- 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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