This is a contract position. While the contract length is not guaranteed, it is expected that the duration will be at least six months. It could easily be much longer if you produce high quality deliverables and help your project teams achieve their objectives. PLEASE ONLY APPLY if you are looking to start a new project within the next 2-6 weeks.
Our consultants are insanely talented and are personally motivated to exceed expectations. As a Computer Systems Validation (CSV) Consultant, you will facilitate discussions with client personnel to discover, assess, plan, and execute technology system implementations within a GxP context. You will work with your project manager and client personnel to understand overall project objectives. You will author validation plans, user requirements documents and/or system requirements documents, and traceability matrices. You will author and review testing plans and scripts (IQ/OQ/PQ), execute test plans and scripts, prepare test summary reports, and prepare final validation reports.
You will work directly with project leaders and client personnel and often interact with people from other organizations. You communicate well with business stakeholders, project management, IT leadership, and technical resources. You can blend in with any team but always standout through consistent delivery of high quality work products and exceptional communication skills. You thrive in challenging environments, where the path forward is not always clear at the outset. You are grounded in solid project management and system validation methodology and set and manage expectations extremely well. You work effectively with others and are exceedingly productive on your own. You are a problem solver and a life-long learner. You continually develop yourself to be the best you can possibly be!
- Must be eligible to work in the United States
- Must possess a degree from an accredited, four-year college or university; advanced degrees and certificates/certifications are highly desirable (e.g. PMI-PBA, CAPM, PMP)
- Must possess at least two years of relevant work experience as a computer system validation (CSV) analyst in the biotech/pharmaceuticals industry; knowledge of applicable regulations (e.g. GxP, SOX) is highly desirable
- Must be able to handle multiple projects and competing priorities with a proven track record of quality results
- Must communicate exceptionally well, both in writing and verbally
- Must possess mastery skill using Microsoft Word and Excel
- Experience with Microsoft Office 365, PowerPoint, Visio, Microsoft Project, SharePoint, OneNote, and Skype are desireable
- May live anywhere within the United States but strong preference will be given to those located in the San Diego, CA or San Francisco, CA
- Must be willing to travel to client sites as needed