Head of Process Automation, Foster City Biologics Manufacturing
Core
Define and execute the site process automation strategy, operating model, and lifecycle roadmap for DeltaV-based process equipment supporting biologics manufacturing at the Foster City New Chess Facility and Pilot Plant.
Role type
Head of Process Automation (Manufacturing)
Builds
DeltaV process control systems, automation ecosystem, and support models for GMP and non-GMP biologics drug substance manufacturing.
Domain
Biologics Manufacturing / Process Automation / Pharma
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DeltaV system architecture and configuration, GxP compliance and data integrity, OT cybersecurity, team building and leadership, lifecycle management, project execution, vendor management, batch control strategy, alarm philosophy, historian integration, recipe governance, incident management, change control, CAPA execution, KPI development.
Preferred skills
AI implementation in manufacturing, technology transfer, facility expansion planning, cross-functional collaboration.
Technologies
DeltaV, MES, Process Parameter management, BAS, ERP, LIMS, Historian, analytics platforms.
Responsibilities
Define and execute the automation roadmap for DeltaV process control systems; establish site process automation standards, governance, and lifecycle management processes; own the DeltaV platform supporting GMP and non-GMP process equipment; build, lead, and scale a fit-for-purpose process automation organization; account for site process automation deliverables for design reviews, FATs, SATs, commissioning, qualification, and startup; establish procedures and governance for automation incident management, change control, deviation support, and CAPA execution; lead troubleshooting of complex automation and batch execution issues; ensure compliance with GxP, 21 CFR Part 11, Annex 11, data integrity requirements, and corporate quality standards; lead OT cybersecurity activities for process automation systems.
Seniority
Senior, hands-on IC with leadership responsibilities
