Validation Engineer III

Duration: 12 Months +

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 Clients’ 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

Shift: Day

This role is 100% onsite.