vTek Systems Inc
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The Automation Engineer will support, design, implement, and maintain automated systems within a GMP-regulated pharmaceutical or biotech manufacturing environment. The role ensures that automation systems (such as SCADA, DCS, PLCs, DeltaV, MES, BMS, etc.) are compliant with 21 CFR Part 11, data integrity, and validation requirements, while enabling efficient and compliant manufacturing processes.
Responsibilities
Design, develop, and maintain automation systems and control strategies for GMP manufacturing equipment and utilities (e.g., reactors, CIP/SIP systems, autoclaves, HVAC, WFI, clean steam). Support system integration and interface with MES, LIMS, Historian, and other plant-level systems. Participate in FAT, SFAT, SAT, IOQ, and commissioning activities for new or modified equipment. Author and execute validation documents (URS, FRS, DDS, IOQ protocols). Troubleshoot and resolve automation-related issues and support root cause investigations. Maintain and modify PLC/HMI/DCS code (e.g., Allen Bradley, Siemens, DeltaV, Rockwell). Ensure systems meet FDA, GMP, GAMP5, and data integrity compliance standards. Collaborate cross-functionally with QA, Manufacturing, Validation, and IT teams. Provide automation change control documentation per site policies and SOPs. Maintain and track software version control and backup systems for automation code. Qualifications
Bachelor’s degree in Electrical Engineering, Automation, Computer Science, or related field. 3+ years of automation experience in a regulated pharmaceutical, biotech, or medical device environment. Hands-on experience with PLCs, SCADA, DCS (e.g., DeltaV, Siemens PCS7, Rockwell). Familiarity with GMPs, FDA regulations, GAMP5, and 21 CFR Part 11. Understanding of batch processing, S88, and data integrity principles. Strong troubleshooting, documentation, and communication skills. Preferred Skills
Experience with Emerson DeltaV, Wonderware, Rockwell FactoryTalk. Experience with MES systems (e.g., Werum PAS-X, Syncade). Knowledge of network and cybersecurity principles for industrial control systems. Experience with electronic batch records, alarm management, or PAT tools.
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Design, develop, and maintain automation systems and control strategies for GMP manufacturing equipment and utilities (e.g., reactors, CIP/SIP systems, autoclaves, HVAC, WFI, clean steam). Support system integration and interface with MES, LIMS, Historian, and other plant-level systems. Participate in FAT, SFAT, SAT, IOQ, and commissioning activities for new or modified equipment. Author and execute validation documents (URS, FRS, DDS, IOQ protocols). Troubleshoot and resolve automation-related issues and support root cause investigations. Maintain and modify PLC/HMI/DCS code (e.g., Allen Bradley, Siemens, DeltaV, Rockwell). Ensure systems meet FDA, GMP, GAMP5, and data integrity compliance standards. Collaborate cross-functionally with QA, Manufacturing, Validation, and IT teams. Provide automation change control documentation per site policies and SOPs. Maintain and track software version control and backup systems for automation code. Qualifications
Bachelor’s degree in Electrical Engineering, Automation, Computer Science, or related field. 3+ years of automation experience in a regulated pharmaceutical, biotech, or medical device environment. Hands-on experience with PLCs, SCADA, DCS (e.g., DeltaV, Siemens PCS7, Rockwell). Familiarity with GMPs, FDA regulations, GAMP5, and 21 CFR Part 11. Understanding of batch processing, S88, and data integrity principles. Strong troubleshooting, documentation, and communication skills. Preferred Skills
Experience with Emerson DeltaV, Wonderware, Rockwell FactoryTalk. Experience with MES systems (e.g., Werum PAS-X, Syncade). Knowledge of network and cybersecurity principles for industrial control systems. Experience with electronic batch records, alarm management, or PAT tools.
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