What are the responsibilities and job description for the Validation Engineer position at Kellton?
Job Details
Position: CSV Engineer
Duration: 12 months contract with possible extension
Location: Portsmouth, NH 03801 (100% Onsite)
No C2C- H1 tranfers are welcome
This role is a senior CSV engineer requirement. 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
