CSV Engineer
CSV Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location: Rocky Mount NC Onsite
Duration: 12 Months
You will be responsible for
Resolution of fundamental Computer System Validation compliance issues on assigned projects
Writing reviewing and executing computer validation documentation
Perform computer system validation activities related to process control systems of pharmaceutical water for injection system water pretreatment system water stills and high quality steam generation systems
Validation of computerized systems in accordance with GAMP5 and VModel (USR Function Specification IQ/OQ/Protocol/Report/Testing Traceability Matrix Validation Report)
Assessing electronic/paper records aiming to identify Data Integrity gaps with RiskBased Approach in order to suggest the most appropriate mitigation/remediation actions
Ensuring that all projectrelated issues and deviations are recorded approved and dispensed accordingly
Preparation of project and life cycle reports and review/approve all other documents to ensure compliance with SOP
Ensuring that all project and lifecycle documents achieve the goal of traceability and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP
About you:
At least 5 years s of experience in the Pharmaceuticals field with focus on Computer System Validation
Previous work experience in computer system validation of PLCs HMIs SCADA and historian.
Experienced in computer system validation of Rockwell Factory Talk Microsoft SQL Server Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems.
Ability to perform input and output testing.
Strong understanding of FDA regulations for commissioning validation and lifecycle management of GMP equipment and process control systems.
Strong knowledge in good documentation practices.
Knowledge of Data Integrity Assurance according to EU GMP Annex1 US FDA Annex 11
Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP 21 CFR part 11.)
Employment Type
Full Time
