Computer System Validation Engineer III

4 weeks ago


Portsmouth, United States VIVOS Professional Services, LLC Full time

This role is a

senior CSV engineer

requirement based in

Portsmouth NH. This is a

contract

role. Payrate for the role is

$55-$65

an hour Not a C2C Role.

Requirements: CSV /Automation experience of 5+ years Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. Experienced at working independently as well as in a team-oriented, collaborative environment is essential Author, Review, Approve and Execute CSV life cycle documentation Experience working with and programming/commissioning/validating Delta V software platforms Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems Manage, document, and assess the software changes throughout the SDLC following *** procedures. Knowledgeable of S88 Batch Standard is preferable Recipe management DeltaV software development and testing is preferable MES Recipe authoring and testing is preferable Implementation and validation of QC system is preferable Experience with Kneat is preferable Strong verbal and written communication skills This role is 100% onsite.

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