Automation Validation Engineer Job

A Automation Validation Engineer is needed to perform the following duties:

· · Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems as directed by division manager.

· Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).

· Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.

· Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.

· Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.

· Support commissioning and qualification (C&Q) activities for DeltaV DCS and Emerson MES systems.

· Develop and execute Commissioning Test Protocols (CTP), IOQ protocols, and final validation

· reports.

· Create Requirements Traceability Matrices (RTM) and DeltaV decommissioning protocols.

· Conduct hands-on Site Acceptance Testing (SAT) for automated utilities and control systems.

· Leverage experience with Emerson DeltaV and Rockwell PLCs for control system development and testing.

Bachelor's Degree in Computer Science or Computer Engineering or Information Technology Project Management

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave