What are the responsibilities and job description for the GxP Lab Computing Engineer position at VSolve Global Consultants?
Job Details
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