Specialist, Shutdown Coordinator
Core
Oversee facility-related activities and projects during plant shutdowns, ensuring safety, budget compliance, and timeliness for a biopharmaceutical manufacturer.
Role type
Specialist Shutdown Coordinator
Builds
Shutdown schedules, action lists, and coordination plans for manufacturing facility outages
Domain
Biopharmaceutical manufacturing / cGMP regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, cGMP principles, FDA-regulated environment experience, safety compliance, vendor coordination, Microsoft Project, stakeholder management, regulatory knowledge, documentation management, asset planning evaluation
Preferred skills
SAP experience, engineering degree
Technologies
Microsoft Project, Microsoft Word, Microsoft Excel, Windows, SAP
Responsibilities
Develop comprehensive shutdown schedules using project management software; create and oversee shutdown planning action lists; chair daily shutdown planning coordination meetings; conduct compliance and safety audits; manage relationships with Maintenance, Validation, Quality, and Operations leadership; establish preparatory work for equipment downtime; evaluate asset planning and coordination strategies; ensure timely documentation and adherence to policies.
Seniority
Specialist, hands-on IC