Maintenance Responsibilities:Perform preventive and corrective maintenance on equipment and automation systems and Diagnose technical failures and implement solutions to ensure operational continuity and Document all maintenance activities and update maintenance records
SCADA Systems Management: Monitor and maintain SCADA systems from IMA, GEA, Sartorius, Ortner and Groninger and Update and modify SCADA programs as necessary for improvements and production requirements and Ensure the integrity and security of SCADA systems in accordance with company policies
Pharmaceutical Automation Knowledge: Familiarity with GAMP5 (Good Automated Manufacturing Practice) for the validation of automated systems and Expertise in pharmaceutical manufacturing environments and GxP (Good Practice) requirements, including GMP (Good Manufacturing Practice) and Experience in maintenance and operation within controlled environments, including clean rooms
Documentation and Compliance: Maintain comprehensive maintenance and software change documentation in compliance with regulatory standards and Act as SME and attend validation reports, qualification protocols (IQ/OQ/PQ), and internal and external audits and Ensure all activities comply with local and international regulatory requirements
Data Management and Reporting: Analyze operational data collected by SCADA systems to identify trends and improvement opportunities and Generate detailed technical reports on system performance and corrective actions taken and Collaborate with quality and production teams to ensure conformity with regulatory standards
Training and Technical Support: Train operators and maintenance technicians on the proper use of SCADA systems and PLCs, over specific demands and Provide real-time technical support to resolve operational issues and minimize downtime and Conduct continuous training sessions to update teams on new technologies and maintenance practices
Optimization and Continuous Improvement: Create or review Audit Trail Reviews (ATR) on ongoing projects, as per company standards and Create or review Standard Operating Procedures (SOP’s) and Propose and implement continuous improvement projects aimed at increasing efficiency and reducing operational costs and Participate in cross-functional teams to develop innovative solutions to automation challenges and Perform periodic audits of automation systems to ensure optimal performance
Compliance and Safety: Ensure all maintenance and automation activities comply with safety standards and pharmaceutical regulations and Actively participate in the company’s safety and quality programs and Investigate and report any incidents or near misses related to automation and implement preventive measures
