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
USDM is looking for a strong Lab Automation Engineer to provide key support throughout the lifecycle of various GMP and non-GMP laboratory projects and systems.
Assist in startup activities and equipment integration to site Data Management System.
Perform 21 CFR Part 11 and EU Annex 11 technical assessments.
Implementing system controls on instruments or associate computers.
Maintain and manage system user access, backups, and on floor support.
Support all GMP, safety, and environmental regulations.
Follow work instructions for system set-up to the site Data Management System and network.
Perform computer setup including network configuration and policy updates.
Complete all GMP documentation for system integration.
Maintain technical documentation.
Manage Tasks based on aggressive timelines.
4 to 5 years of experience in a GMP environment.
Familiarity with Laboratory Equipment.
Familiarity with Laboratory Instruments.
Familiarity with computer setup.
Knowledge of 21CFR Part 11
Knowledge on EU Annex 11.
Strong technical background.
Effective interpersonal and communication skills (written and oral).
Ability to work independently with minimal supervision and adhere to timelines.
Expert in MS Word.
Education & Certification
Associates or Bachelor's degree in Engineering (Chemical, Electrical, Mechanical), Science or Information Technology or related field.
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.
Travel to client site for onsite work as needed.
Equal Opportunity Statement
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.
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.