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A leading company in the biotechnology sector is seeking an Automation Technical Lead to design, develop, and maintain automation systems supporting manufacturing processes. This challenging role requires strong leadership skills and expertise in control systems and regulatory compliance, offering an opportunity to significantly impact operational efficiency in a high-stakes environment.
· Design, develop and maintain good performance of the automation systems to support manufacturing processes.
· Ensure compliance with Standard Operating Procedures (SOPs), Health, Safety and Environment (HSE) regulations and Current Good Manufacturing Practices (CGMPs) within his/her purview.
MAJOR RESPONSIBILITIES:
Project Support
· Automation technical lead in the site capital/operational project i.e new product introductions or new technology introductions by performing automation assessments, implementation and qualification activities.
· Provide technical guidance and oversight to automation/senior automation engineer.
Co-ordination with global automation on site LRP’s.
Operation Support
· Provide technical support to automation systems related issues in manufacturing operations.
· Maintain GMP compliant state of the automation systems.
· Ensure periodic alarm management/audit trail reviews are done
· Ensure periodic preventive maintenance is carried out for all automation systems.
· Ensure periodic review of work order’s related to preventive/demand maintenance.
· Support 24/7 on call operational support.
· Periodic review of automation SOP’s if required
Audit Support
· Automation representative in non-conformance investigations and assist in the implementation of corrective actions.
· Automation representative in external/internal compliance audits.
KEY REQUIREMENTS:
· Degree or Master’s in Engineering (Chemical / Electrical & Electronics / Instrumentation)
· 12 – 15 + years of relevant work experience in Biotechnology / Pharmaceutical is highly preferred.
· Proficiency in programming/troubleshooting in Control Systems (DCS/PLC) applications especially DeltaV, Siemens, Allen Bradley etc.
· Experience in Network Infrastructure/ Virtual Machines – Virtualization, Communication protocol i.e Devicenet, Ethernet/IP, Fieldbus, Profibus, Modbus TCP, Profinet, IO link etc
· Experience in Manufacturing Execution Systems like POMSnet etc
· Experience in Data Historian Systems like OSI PI etc
· Knowledge of GAMP/GMP and familiarity with documentation in regulated environment.
· A self-driven team player with strong communication skills to collaborate, influence and provide technical solutions to both technical and non-technical stakeholders.
· Proven ability to lead automation projects with experience in project management tools and mentor teams of engineers.