-Maintenance Responsibilities:
Perform preventive and corrective maintenance on equipment and automation systems in W34 and W23 buildings.
Diagnose technical failures and implement solutions to ensure operational continuity.
Document all maintenance activities and update maintenance records.
-SCADA Systems Management:
Monitor and maintain SCADA systems from IMA, GEA and Groninger.
Update and modify SCADA programs as necessary for improvements and production requirements.
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.
Expertise in pharmaceutical manufacturing environments and GxP (Good Practice) requirements, including GMP (Good Manufacturing Practice).
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.
Act as SME and attend validation reports, qualification protocols (IQ/OQ/PQ), and internal and external audits.
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.
Generate detailed technical reports on system performance and corrective actions taken.
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.
Provide real-time technical support to resolve operational issues and minimize downtime.
Conduct continuous training sessions to update teams on new technologies and maintenance practices.
-Optimization and Continuous Improvement:
Propose and implement continuous improvement projects aimed at increasing efficiency and reducing operational costs.
Participate in cross-functional teams to develop innovative solutions to automation challenges.
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.
Actively participate in the company’s safety and quality programs.
Investigate and report any incidents or near misses related to automation and implement preventive measures.
Perform preventive and corrective maintenance on equipment and automation systems in W34 and W23 buildings.
Diagnose technical failures and implement solutions to ensure operational continuity.
Document all maintenance activities and update maintenance records.
-SCADA Systems Management:
Monitor and maintain SCADA systems from IMA, GEA and Groninger.
Update and modify SCADA programs as necessary for improvements and production requirements.
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.
Expertise in pharmaceutical manufacturing environments and GxP (Good Practice) requirements, including GMP (Good Manufacturing Practice).
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.
Act as SME and attend validation reports, qualification protocols (IQ/OQ/PQ), and internal and external audits.
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.
Generate detailed technical reports on system performance and corrective actions taken.
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.
Provide real-time technical support to resolve operational issues and minimize downtime.
Conduct continuous training sessions to update teams on new technologies and maintenance practices.
-Optimization and Continuous Improvement:
Propose and implement continuous improvement projects aimed at increasing efficiency and reducing operational costs.
Participate in cross-functional teams to develop innovative solutions to automation challenges.
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.
Actively participate in the company’s safety and quality programs.
Investigate and report any incidents or near misses related to automation and implement preventive measures.
