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Process Specialist Engineer
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 expertise in process engineering, computer system validation, and technical troubleshooting, supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence.
Requisitos: Requirements: Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field). Demonstrated experience in oral solids manufacturing processes, specifically tablets. Previous experience in handling problem solving and research associated with tablet manufacturing equipment and processes (mixing, compression, coating, compaction in Roller Compactor) Extensive experience in process engineering, validation, metrology, and quality assurance within pharmaceutical or biotech manufacturing. Strong knowledge of 21 CFR Part 11, GAMP, and validation of automated systems (SCADA, PLCs, HVAC, water systems, utilities). Demonstrated ability to perform technical troubleshooting on equipment and computerized systems. Experience with investigations, deviations, and CAPA management. Experience in project management, facility start-ups, equipment commissioning, and system upgrades. Proficiency in developing protocols, SOPs, risk assessments, and validation documenta Requiere Mucha Experiencia Requires Expert
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QRC GROUP LLC
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