Automation SME
On-siteGaithersburg, Maryland, United States
Job Summary
Lead technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, and clean utility systems. Develop and review automation architecture, control strategies, functional specifications, batch recipes, and system design documentation. Oversee system integration, commissioning, qualification, and validation activities, ensuring compliance with GMP, GAMP 5, ISA-88, ISA-95, and data integrity standards. Collaborate with cross-functional teams to define process control requirements and support digital manufacturing initiatives. Provide technical guidance to vendors and internal teams while managing risk assessments and alarm management.
Required Qualifications
- Bachelor's or Master's degree in Automation, Electrical, Controls, Chemical, Process Engineering, or a related technical discipline
- 8+ years of experience supporting automation systems in GMP biologics or pharmaceutical manufacturing environments
- Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, process historians, MES/LIMS integration, and industrial networking
- Hands-on experience with biologics manufacturing processes, including bioreactors, chromatography, UF/DF, filtration, CIP/SIP, and clean utilities
- Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles
- Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support
- Excellent communication, technical leadership, and cross-functional collaboration skills
Desired Qualifications
- Preferred certifications include ISA CAP, GAMP, Functional Safety, or relevant automation platform certifications
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