Computer Systems Validation Jobs in Libertyville (IL)
work activities of moderate to high complexity.
Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computersystemvalidation in support...
- Must have Project Management experience in building all layers of IT infrastructure
- Must have GMP and computersystemsvalidation experience in pharmaceutical...
systemvalidation.
" Familiarity with ERP systems (i.e. SAP or QAD), MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV), OSI PI, EBRs (i.e. InfoBatch) and IT system integrations.
" Dashboard development / Tableau knowledge is a plus...
Data Center Build out, Infrastructure modernization, Legacy Infrastructure migration, Cloud migration). Must have Project Management experience in building all layers of IT infrastructure
Must have GMP and computersystemsvalidation experience...
results-driven environment.
Understanding of computersystemvalidation.
Familiarity with ERP systems (i.e. SAP or QAD), MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV), OSI PI, EBRs (i.e. InfoBatch) and IT system integrations...
- Understanding of CSV / CSA (computersystemvalidation/ computersystem assurance) with cloud based/ digital systems
- Experience on GAMP
- Understanding of latest FDA and EMA guidelines
- Exposure to Good practices (Clinical...
systemvalidation.
" Familiarity with ERP systems (i.e. SAP or QAD), MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV), OSI PI, EBRs (i.e. InfoBatch) and IT system integrations.
" Dashboard development / Tableau knowledge is a plus...
Project management and solution implementation.
At least one (1) of the following tools: Drug Development functions, Clinical, or GMP.
Waterfall, and Agile.Software Testing and ComputerSystemValidation.
Regulatory knowledge on 21 CFR part 11, part...
Signatures regulations compliance and validation approaches across projects to ensure compliance with regulations, and Company policies and procedures.
Responsible for reviewing and approving ComputerSystemValidation documents to ensure compliance...
- Identify and develop all required computersystemvalidation deliverables including but not limited to validation plan, user and functional requirements, regulatory...