Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation
Core
Subject matter expert in automation engineering driving innovation and solving complex challenges for upstream and downstream bioprocessing automation systems.
Role type
Principal Manufacturing Systems Engineer (Process Automation)
Builds
Automation systems for drug substance manufacturing (FleX Batch facility) integrating disposable technologies and Industry 4.0 capabilities.
Domain
Biopharmaceutical manufacturing (Upstream/Downstream)
Deliverable
production ML models | product features | infrastructure
Required skills
Automation system design and implementation, GMP compliance, Emerson DeltaV DCS, Commissioning and Qualification (IV/ACO), Process control strategy, Technical mentorship, Cross-functional leadership, Data integrity management, Continuous improvement initiatives.
Preferred skills
Electrical/Computer/Chemical/Biotech Engineering degree, Process Control Network design, Virtual Infrastructure design, System Integration (OPC, Foundation Fieldbus, Profibus), IO-Link technology, Process Analytical Technology (PAT), OEM automation software integration, Regulatory standards (21 CFR Part 11, S88, S95, GAMP, GDP, GMP), Biopharmaceutical process knowledge (Seed train, Bioreactors, Chromatography, UFDF, CIP/SIP).
Technologies
Emerson DeltaV, OPC, Foundation Fieldbus, Profibus, IO-Link, PAT tools.
Responsibilities
Lead commissioning and qualification of process equipment automation, Develop process control automation solutions, Provide 24/7 onsite/on-call automation support and troubleshooting, Perform automation change assessments and configuration changes, Mentor junior engineers and cross-functional teams, Influence automation strategy and standardization across the site.
Seniority
Principal, strategic leadership with hands-on technical execution
