Equipment Specialist
PharmaMedTechRegulatory AffairsQuality Assurancegmpemacroinformsap
Job description
Salary Range: 26.000,00 € - 48.400,00 € Job Description Summary The Equipment Specialist ensures the reliability, availability, and GMP compliance of the electronic, electrical, and automation systems installed on secondary packaging lines for ophthalmic products. The role is responsible for ensuring the proper operation of equipment and minimizing plant downtime through the execution of preventive, corrective, and continuous improvement maintenance activities, leveraging technical analysis, advanced troubleshooting, and the implementation of improvement solutions integrated into preventive maintenance plans. Job Description Key Responsibilities Perform preventive and corrective maintenance activities on automated secondary packaging lines, ensuring the rapid restoration of operational conditions. Diagnose and troubleshoot electrical, electronic, and automation-related faults, conducting root cause analyses and implementing corrective actions. Manage and maintain industrial automation systems, including PLCs, HMIs, inverters, servo drives, and industrial networks. Collaborate with vendors, system integrators, and cross-functional teams on equipment upgrades, validation activities, and technical deviation management. Maintain and verify vision inspection and serialization systems, ensuring performance, regulatory compliance, and operational reliability. Support line start-up activities, format changes, change control processes, CAPA implementation, and technical investigations. Operate in compliance with GMP, Data Integrity, EHS requirements, and company SOPs, ensuring accurate maintenance and technical documentation. Contribute to continuous improvement initiatives focused on equipment reliability, TPM, digitalization, downtime reduction, and maintenance KPI monitoring. Essential Requirements Technical Diploma in Electronics, Electrical Engineering, Industrial Automation, or a related field; a Bachelor's Degree in Electronic Engineering, Automation Engineering, or Mechatronics is considered a plus. Proven experience in the electronic maintenance of automated equipment, preferably within the pharmaceutical, medical device, or food industries, with knowledge of automated packaging lines. Ability to read and interpret electrical schematics and P&IDs, perform PLC diagnostics, and carry out basic PLC/HMI programming activities. Proficiency in the use of diagnostic instruments such as multimeters, oscilloscopes, and other troubleshooting equipment. Knowledge of industrial vision systems, GMP and Data Integrity principles, and computerized maintenance management systems (CMMS/SAP PM or equivalent). Experience in Root Cause Analysis using structured methodologies such as 5 Why, Fishbone, and FMEA; knowledge of pharmaceutical serialization systems, OT cybersecurity, and technical English is considered an advantage. Strong problem-solving skills, a safety and quality-oriented mindset, and the ability to work effectively within multidisciplinary teams and high-pressure manufacturing environments. Experience contributing to the definition and monitoring of maintenance KPIs, including MTTR, MTBF, line availability, preventive maintenance compliance, reduction of unplanned downtime, timely closure of CAPAs/deviations, and GMP compliance. Work Schedule Availability to work on shifts and provide technical on-call support according to the operational requirements of the manufacturing site. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired Forklift Operations, GMP Compliance, Health, Safety, and Environment (HSE) Policy, Inventory Management, Machine Operations, Manufacturing, Operations Management, Process Improvements, Production Management, Quality Control (QC), Regulatory Documents
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