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Process Engineer
Provide day-to-day 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 preparation of qualification reports and supporting documentation.
Prepare and maintain SOPs, disaster recovery plans, backup strategies, and system configuration documentation.
Conduct Quality Risk Assessments and Qualification Risk Assessments for equipment, utilities, and computerized systems.
And more...
Requisitos: Requirements: Requirements Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field). 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 in project management, facility start-ups, equipment commissioning, and system upgrades. Proficiency in developing protocols, SOPs, risk assessments, and validation documentation. Experience with investigations, deviations, and CAPA management. Strong communication, teamwork, and leadership skills. Requiere Mucha Experiencia Requires Expert
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