Principal Automation Engineer

Responsibilities

• Function as Automation Project Lead for a large-scale greenfield manufacturing expansion
• Evaluate and recommend the preferred automation integration platform for a new facility
• Establish automation requirements for site process control, independent bioprocessing skids, and building management systems
• Establish requirements for plant data historian system
• Establish requirements for IT/OT infrastructure and system integration
• Evaluate distributed control system (DCS) and plant control systems (PCS) to define best platform for new production facility based on site location and functionality
• Develop Manufacturing Execution System (MES) platform and integration requirements
• Capture Manufacturing Execution System (MES) and process data collection for Electronic Batch Records (EBR) implementation
• Support of industrial control systems
• Manage contract resources for Automation Integration, plant data historian integration, and Manufacturing Execution Systems integration
• Coordinate Commissioning, Qualification, Validation (CQV) activities and function as primary point of contact on automation projects for CQV

Qualifications

• Bachelor’s / Master’s degree or equivalent
• Postgraduate, certification, and/or license may be required
• 10+ years relevant experience for this leadership position
• Demonstrated communication skills, including verbal and written communication, in contact with vendors, internal customers, and employees
• Knowledge of Good Manufacturing Practices (GMP), good automation manufacturing processes (GAMP), and Good Documentation Practices (GDP)
• Knowledge of data integrity and 21CFR11 requirements and for the design qualification of Biotech/pharmaceutical GMP computerized systems
• Knowledge of computerized systems’ server and personal computer hardware, networking, operating systems, integrated architecture, cyber security and resiliency
• Knowledge of automation standards including ISA-88 (S88), ISA/IEC 62443,ISA-95, and ISA-101
• Knowledge of OSHA, local safety guidelines, lock-out tag-out, and hot work permits