Job Description :
VDart We are a Global Information Technology Services & Workforce Solutions firm headquartered out of Atlanta, GA with presence in US, Canada, MX, UK, Belgium, Japan & India. Founded in 2007, Our team of over 2550+ professionals continually create impact for our customers worldwide in solving complex technology challenges with cutting edge technologies. We specialize in providing the Fortune 1000 companies, niche hard to find skills in technologies including Social, Mobile, Big Data Analytics, Data Sciences, Cyber Security, IoT, Cloud, Machine Learning, and Artificial Intelligence. With delivery centers in the UK, Mexico, Canada, and India, we provide global workforce solutions to our customers covering EMEA, APAC & Americas. VDart is an award-winning organization recognized by Inc 5000 Hall of Fame; Atlanta Business Chronicle*s Fastest Growing Companies; NMSDC*s National Supplier of the Year; Ernst & Young*s Regional Entrepreneur of the Year and more. Title: LABX Validation - Senior Technical Lead Location: Durham, NC Duration: 6 to 9 months Job Qualifications: 10+ years of Lab Systems validation experience is required. Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years' experience with LabX method development and validation preferred. Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures) Understanding of Data Integrity concepts is required Excellent communication and written skills required Job Responsibilities: Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler) Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc. Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs Coordinate alignment of systems users from various company groups on validation and qualification documentation Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc. If your skills match our requirements, Share resume to Be sure to reference the job number and title in the subject line. Referral Program: Ask our recruiting team about how you can be a part of our referral program. If you refer a candidate with this background and if the candidate accepts the role our team pays a generous referral. We are keen on networking and establishing a long-term, mutually beneficial partnership with you. We are Equal Employment Opportunity Employer. VDart Inc Alpharetta, GA Click here to Apply Follow us on Twitter for the hottest positions: @VDart_Jobs Follow us on Twitter: @vdartinc