Manufacturing Systems Engineer: Automation
Core
Develop and maintain process control systems and automation platforms for GMP Drug Substance Plant Operations, integrating new manufacturing technologies.
Role type
Senior Manufacturing Systems Engineer (Automation)
Builds
Robust process automation systems for a new biopharmaceutical drug substance manufacturing plant.
Domain
Biopharmaceutical manufacturing / Industrial Automation
Required skills
Emerson DeltaV DCS, GxP compliance, Data Integrity Assessments, Change Control management, Root Cause Analysis, Functional Safety, Vendor FAT support, Commissioning/Qualification, Continuous Improvement, Technical Documentation
Preferred skills
Electrical/Chemical Engineering degree, GAMPs knowledge, 21 CFR Part 11, ASTM 2500, S88/S95, OPC/Foundation Fieldbus/Profibus, Bioreactor/Chromatography/TFF automation, Single-use technologies
Technologies
Emerson DeltaV, OPC, Foundation Fieldbus, Profibus
Responsibilities
Develop and maintain process control systems; Collaborate with stakeholders to synthesize process requirements; Provide documentation for solutions; Support QA in computerized systems validation; Perform Data Integrity Assessments; Support vendor FAT; Drive Change Controls and CAPAs; Support root cause analysis and troubleshooting; Prepare/review SOPs and cGMP documents.
Seniority
Senior, hands-on IC
