Job details
Salary $50 - $75 an hour job type full-time contract number of hires for this role 1
Full job description
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.
Job types: full-time, contract
Pay: $50.00 - $75.00 per hour
Schedule:
8 hour shift
Work location:
Fully remote
Work location: remote
