Manager Automation
Core
Supervising a team responsible for cGMP automation quality systems, software change control, and automation-related corrective actions to ensure manufacturing systems operate as expected.
Role type
Manager, Automation Systems
Builds
Manufacturing process equipment configurations, cGMP software administration programs, and corrective action projects
Domain
Biopharmaceutical manufacturing / Automation / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP software quality system principles, data integrity regulations, automated control systems design/installation/maintenance, team mentorship, technical presentation to multi-functional departments, project management for corrective actions, validation support (design review/testing/protocol review)
Preferred skills
Bioprocessing knowledge, business and technical savvy, ability to balance changing priorities
Technologies
Automated control systems, cGMP software
Responsibilities
Managing team performance, training, and development; providing technical and automation support to manufacturing; overseeing configuration and support of manufacturing process equipment; managing periodic evaluation reports for automated systems; overseeing investigation of manufacturing deviations and anomalies; managing projects related to corrective action or equipment performance improvement; implementing modification/change control procedures; supporting validation activities
Seniority
Manager, hands-on leadership