Computer System Validation Engineer III
4 weeks ago
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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