Process Engineering Specialist

The Process Engineer is responsible for ensuring the reliability, compliance, and performance of manufacturing processes, equipment, utilities, and computerized systems within a pharmaceutical or biotechnological environment. This role requires strong experience in oral solid dose (OSD) processes, processes such as dry granulation, mixing, compression, coating and packaging (preferably bulk packaging) and strong expertise in process engineering, computer system validation, and technical troubleshooting, supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence. Provide daytoday troubleshooting for manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations. Lead and execute the Computer Validation Life Cycle (CVLC) for systems such as SCADA, PLCs, smart instruments, and networked control systems. Develop and execute FAT, IQ, OQ, and PQ protocols, including preparat...