QA / CSV Engineer - EBS / SAP
Company: USDM Life Sciences
Location: Santa Monica
Posted on: May 11, 2022
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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
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