Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Description:
This is 100% Onsite
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) / BAS (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 Client 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