Description

You will manage the periodic review process for manufacturing automation systems within a GMP environment, scaling from approximately 35 systems to 200.

This role is on-site.

Responsibilities

• Plan and execute periodic reviews for PLC, SCADA, and MES platforms.
• Assess automation and CSV compliance across manufacturing site systems.
• Manage documentation and review workflows to ensure ongoing GMP compliance.
• Coordinate system reviews to maintain regulatory standards.
• Manage large-scale system review projects effectively.

Required Skills

• 9+ years of experience with manufacturing GMP automation systems.
• Hands-on experience with Rockwell Automation FactoryTalk.
• Experience with MES, PLC, and SCADA technologies.
• Background working with Siemens systems, specifically PCS 7 and Op Center MES.
• Strong understanding of Computer System Validation (CSV) and periodic review processes.
• Proven ability to manage large-scale system review projects.

Preferred Skills

• Background working directly within a manufacturing site environment.

Key Skills

Education

Any Graduate