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Responsibilities:
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 Lonza 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.
Date Posted: 16 May 2024
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