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 growthOur deep domain knowledge and technology expertise in life sciences business processes are what sets us apartFrom 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 moreFrom 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 clientsAre 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 computer system validation engineer with mes/erp (ideally boomi) experience to support our client on a variety of compliance initiatives.
Primary responsibilities
Review mes/erp technical documents, provide feedback and approval.
Draft validation deliverables and execute such as risk assessments, specifications, iq, oq, pq, validation reports, etc.
Draft and provide input on mes/erp part 11 assessment.
Develop user requirements, functional specifications.
Develop test / validation scripts based on requirements.
Develop installation tests / qualifications scripts.
Develop operation tests / qualifications scripts based on functional requirements.
Develop performance tests / qualification scripts.
Interact in a team environment, managing tasks and escalating issues as needed.
Qualifications
Experience in erp/mes (ideally boomi).
Experience validating computer systems in aws.
Experience with computer system interface validation and be able to provide input on current client procedure and strategy.
Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Fluent knowledge of rules and regulations: gamp 5, cfr part 11 compliance and cfr part 210, 211 compliance.
Fluent in microsoft office suite including (excel, power point, visio, project)
Ability to work independently.
Strong organizational/ facilitation/communication skills.
Strong verbal, written and presentation skills.
Education & certifications
University certificate or degree with a minimum of 5 years of related industry exp, or bs in technology & 2-3 years of exp.
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 inclusiveReasonable 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 messageMust 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 employerAll 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 positionIt is not intended to include every job duty and responsibility specific to the positionUsdm life sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
