Senior Automation Engineer
We are seeking a highly skilled Senior Automation Engineer to join a biotech manufacturing team. This role will be responsible for designing, implementing, and maintaining automation systems, including PLC, SCADA, and MES, to support bioprocessing and manufacturing operations. The ideal candidate will have a strong technical background in industrial automation, experience in regulated environments (GMP), and the ability to lead automation projects from concept to completion.
Key Responsibilities:
Design, develop, and maintain PLC, SCADA, and MES systems for biotech manufacturing processes.
Lead automation projects, including system upgrades, modifications, and new installations.
Collaborate with cross-functional teams, including process engineering, IT, and quality assurance, to integrate automation solutions with biotech manufacturing processes.
Ensure compliance with GMP, FDA, and other regulatory standards in automation system design and implementation.
Perform troubleshooting, root cause analysis, and corrective actions for automation-related issues.
Develop and maintain documentation, including functional specifications, validation protocols, and standard operating procedures (SOPs).
Support data integrity, cybersecurity, and system validation efforts related to automation systems.
Train and mentor junior engineers and technicians on automation best practices and system operation.
Required Qualifications:
Bachelor's or Master's degree in Electrical Engineering, Automation, Computer Science, or a related field.
5+ years of experience in automation engineering within a biotech, pharmaceutical, or life sciences manufacturing environment.
Expertise in PLC programming (Allen-Bradley, Siemens, or similar), SCADA systems (Ignition, Wonderware, or equivalent), and MES platforms.
Strong understanding of cGMP, 21 CFR Part 11, and validation requirements for automation systems.
Experience with industrial communication protocols (Ethernet/IP, Profibus, Modbus, OPC, etc.).
Knowledge of historians, data analytics, and integration with enterprise systems (ERP, LIMS, etc.) is a plus.
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