Automation/PLC Engineer

Job scope:

• Act as the primary owner of plant automation systems, including PLC, SCADA, MES, and historian platforms.
• Ensure automation systems comply with data integrity, cybersecurity, and applicable regulatory standards.
• Maintain automation systems in a validated state in accordance with GAMP 5 and cGMP requirements.
• Design, develop, and deploy automation solutions for both new and existing manufacturing processes, including integration with digital manufacturing technologies.
• Serve as the subject matter expert (SME) in the development and review of URS, FS, SDS, HDS, and validation documentation.
• Lead or participate in FAT, SAT, IQ, OQ, and PQ activities for automation-related projects.
• Champion Industry 4.0 initiatives, including predictive maintenance, real-time data analytics, and smart sensor technologies.
• Utilize Lean and Six Sigma principles to enhance process efficiency, minimize downtime, and improve system performance.
• Implement effective alarm management practices and advanced process control methodologies.
• Oversee automation projects throughout the entire lifecycle, from conceptualization to implementation, including budget control, scheduling, and vendor coordination.
• Deliver automation enhancements and expansion projects on time while aligning with operational and business objectives.
• Provide technical expertise, guidance, and mentorship to operations and maintenance personnel.
• Develop and conduct training programs focused on automation troubleshooting, system optimization, and best practices.
• Ensure compliance with regulatory and industry standards, including 21 CFR Part 11, GAMP 5, and cybersecurity frameworks.
• Support internal audits and regulatory inspections related to automation, control systems, and metrology infrastructure.