Development of project plans for implementation of SCADA, DCS, and MES. Build out detailed project schedules, budgets, and work breakdown structure.
Oversight, direction, and coordination of automation system implementation, upgrade, and maintenance.
Development, design, and implementation of defense-in-depth cybersecurity strategy, including hardware, software, and configuration.
Test planning and execution for automation, MES, and IT GMP systems.
Planning and implementation of ICH Q9 Quality Risk Management practices including FMEA, HACCP, Fishbone, and other risk-based approaches.
Review of facilities, equipment, process, procedures, and quality systems for manufacturing operations to determine materially relevant conditions during merger and acquisition.
Management of project management offices providing oversight and management for project portfolio execution.
Supplier audits, management, person-in-plant, and coordination of supplier selection.
