QA / CSV Engineer - EBS / SAP

Company: USDM Life Sciences
Location: Santa Monica
Posted on: May 11, 2022

Job Description:

About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job The Validation Engineer will perform activities related to the different computerized systems. The responsibilities for this validation engineer encompass: Computer system validation, Project management, System Implementation support, and Interaction with multiple departments such as Information Technology, Supply Chain, Logistic, and Quality Assurance. Primary Responsibilities Authoring and editing validation documents. Coordination of tasks during the execution of system validation activities, including review and approval. Communication to project team, stake holders and management. Project Management related to validation activities and collaboration with Project Implementation PMs. Reporting progress and status of all validation activities to designated Kite's Quality Engineering Management. Qualifications 3-5+ years' experience working with EBS and SAP (both preferred) 5+ years' experience working in the Life Sciences industry Ability to deal effectively with executive-level stakeholders as well as outstanding communication skills GxP experience is huge plus Prior experience with managing Veeva RIM, Quality Docs, eTMF solutions is huge plus Education Bachelor's Degree in Engineering/Computer Science/Integrated Manufacturing disciplines Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. Operate other office productivity machinery, such as a calculator, scanner, or printer. Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. USDM Life Sciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Keywords: USDM Life Sciences, Santa Monica , QA / CSV Engineer - EBS / SAP, Professions , Santa Monica, California