Job Description

IMPORTANT NOTE:

This is a contract position. PLEASE ONLY APPLY if you are looking to start a new project within the next 2-6 weeks.

RESPONSIBILITIES:

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.

EXPECTATIONS:

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!

MINIMUM REQUIREMENTS:

• 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 - three 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 Teams are desirable
• 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

Company Description

Project Outlier is a management consulting firm that helps biotechs and pharmaceuticals complete important projects. We help our clients via core service offerings including: project management, program management, portfolio management, process improvement, and business analysis. On average, our team members have worked with more than a dozen pharma/biotech organizations. We have helped startups launch their first FDA-approved therapies. We have helped clients extend their marketing and service presence to the Internet. We have also helped globally-recognized brands complete monumental business transformations. While each client and situation are unique, no problem is too big or too small when you have the right strategy and the right team. Our Core Values: • Personal Responsibility. We are as strong as our weakest link so we individually strive to be the best we can be. We lead ourselves well, are self-disciplined, take responsibility for our own growth and development, are organized, maintain the highest ethical standards, and bring a positive outlook to work every day. We work hard even when nobody is watching. • Expertise. We don’t know everything but do know how to define, lead, and execute projects that achieve desired results. We continually expand our current knowledge, deepen and develop new skills, obtain marketable credentials, and build valuable experiences. • Productivity. Actions speak louder than words. Results speak louder still! We focus on substantial improvement and deliver it with the right quality and in a timely fashion. We solve problems, create positive change, and deliver lasting improvements for ourselves and our clients. Simply put, we get stuff done! • Teamwork. All for one and one for all, we succeed or fail as a team. We listen attentively, speak candidly, and treat others respectfully. We communicate effectively, collaborate, foster trust and cohesion, and promote healthy competition that pushes ourselves to be our individual and collective best. • Client Success. We work relentlessly to help our clients achieve their objectives. We emphasize high quality service delivery, maintain a “how can I help?” posture, execute their projects as if they were our own, and celebrate their achievements.