Comprehensive coordination of design, engineering, commissioning, and qualification activities for facilities and systems.

• Turn-key engineering or facility design projects
• Product and facility lifecycle management
• Quality assurance and quality control
• Product launch readiness and commercialization

Oversight of multiple initiatives, aligning resources, priorities, and timelines to maximize impact and ROI.

• Project portfolio and resource planning
• Business process improvement

Project leadership for transferring products between facilities or partners—ensuring compliance, consistency, and operational readiness.

• Manufacturing technology transfer from site to site
• Product and technology development

Development of business cases, CapEx budgets, schedules, and execution plans for facility expansion, retrofits, or new process equipment.

Alignment of project objectives with current Good Manufacturing Practices (cGMP) and support for FDA, EMA, or global regulatory requirements.

• Regulatory submission and compliance
• Quality assurance and quality control

Planning and managing the deployment of Manufacturing Execution Systems (MES), LIMS, and other critical software tools.

• MES system deployment
• Information technology for process control