Associate Director, Site Automation OT Equipment
Core
Lead automation teams and drive accountability for cGMP automation quality systems, software change control, and equipment procurement/qualification across manufacturing and testing labs.
Role type
Senior IC automation operations leader (Associate Director)
Builds
Automated control systems and equipment for pharmaceutical/biopharmaceutical manufacturing and testing
Domain
Biopharmaceutical manufacturing / cGMP regulated environment
Required skills
cGMP quality systems, automated control systems design/installation/maintenance, vendor management, equipment qualification, team leadership, budget forecasting
Preferred skills
MBA/MS, advanced degree, experience with software change control processes
Technologies
Automated control systems, software lifecycle documentation
Responsibilities
Lead automation team and set compliance expectations; oversee cGMP software administration and periodic evaluation programs; support investigations for manufacturing deviations and automation issues; lead corrective action and equipment performance improvement projects; maintain budget forecasts and headcount planning; support vendor relationships and oversee equipment procurement and qualification.
Seniority
Senior, hands-on IC with team leadership