ElevateBio · 10 hours ago
Engineer II, Automation
Pittsburgh, PA
Full-time
Onsite
Mid, Senior Level
6+ years expElevateBio is a technology-driven cell and gene therapy company focused on transforming medicine through innovative technologies. The Automation Engineer II will manage control and automation systems, ensuring compliance and operational efficiency while collaborating with various teams to support manufacturing and quality processes.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
Manage control and automation systems projects through the entire project life cycle and ensure that systems are maintained in compliance state after go live
Work hand in hand with Facilities, Engineering, MSAT and Operations teams to support their projects and operational needs
Troubleshoot issues with facilities control systems, automation systems or related infrastructure to ensure and improve manufacturing performance (e.g. yield improvements, etc.) while maintaining all those systems in compliance with cGMPs
Provide configuration, development, and break/fix day-to-day support of automation systems
Manage automation system documentation and SOPs, prepare technical and user documentation, and conduct system training
Lead automation-related investigations into Quality Event Reports and implement the necessary corrective actions
Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts)
Coordinate with business users for development of reports (batch, material, audit trails, etc.) to support efficient operations
Manage automation contractors supporting projects, day-to-day systems operations, planned and unplanned maintenance activities and ensure they comply with safety and quality systems
Qualification
Required
Bachelor's degree in Engineering, Science, or related technological field
6+ years' experience in life-science regulated environment (e.g. FDA) with working knowledge of the regulatory requirements for pharmaceutical applications
4+ years' experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc
Experience with PLCs (e.g. Allen Bradley & Siemens), SCADA (e.g. Ignition), Batch Operations (S88/S95), OSI Soft Pi Historian, BMS/BAS (e.g. Siemens Desigo)
Control panel and automation hardware and infrastructure design experience
Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5
Requires working in a pharmaceutical industrial manufacturing environment including gowning, desired with experience in aseptic operations
Company
ElevateBio
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase