Overview
On Site
Full Time
Skills
21 CFR Part 11
GAMP
Reporting
Change Control
Documentation
Computer Science
Science
Pharmaceutics
API
Manufacturing
Computerized System Validation
Communication
Job Details
Summary :
We're looking for dedicated, innovative and driven talent to join our expanding team as we are currently looking to hire an CSV Engineer to join our projects team in Wilson, NC supporting multiple projects with the world's leading Pharmaceutical and Biotech company.
Roles & Responsibilities:
Education & Experience:
We're looking for dedicated, innovative and driven talent to join our expanding team as we are currently looking to hire an CSV Engineer to join our projects team in Wilson, NC supporting multiple projects with the world's leading Pharmaceutical and Biotech company.
Roles & Responsibilities:
- Automation Change Review and Approval
- Experience with Emerson Delta other DCS System
- Develop and complete continuous improvements as part of the validation team- Co-ordination of changes to ensure timely delivery.
- CSV Deliverables including 21CFR11 Assessments Annex 11 Assessments Business Criticality Assessments GAMP Assessments
- Installation and Operation Qualification (IOQ) Protocol Generation Execution and Reporting for DeltaV DCS
- Test specification pre-approval review and post approval prior to progression to IOQ- Change Control Impact Assessments
- Maintenance Review and Approval of site Quality documentation
Education & Experience:
- BS in Engineering, Computer Science, Science or other technical degree.
- 4 to 5 years' experience of working in a pharmaceutical API manufacturing operation is desirable.
- Experience with CSV using DeltaV environment
- Candidates will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
- Must be available to work onsite at Wilson, NC.
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