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.
