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Job Role:
The Technician is responsible for ensuring the reliable operation and maintenance of equipment within our sterile manufacturing facilities. This role requires strict adherence to safety protocols, regulatory standards, and continuous improvement practices.
Compliance: Strictly adhere to current Good Manufacturing Practices (cGMP), sterile area protocols, and standard operating procedures (SOPs) during all tasks.
Equipment Maintenance: Execute preventive, corrective, and breakdown maintenance on sterile area equipment to minimize downtime.
Qualification & Validation: Assist in the setup, calibration, accuracy testing, and performance reviews to ensure sterile equipment meets required standards.
Cross-Functional Collaboration: Work closely with Quality Assurance (QA), Production, and Engineering teams to prevent production interruptions.
System Management: Utilize the SAP system efficiently for maintenance scheduling, managing work orders, and tracking spare parts inventory.
Documentation: Maintain highly accurate and compliant records in accordance with Good Documentation Practices (GDP).
Safety Assurance: Actively identify and mitigate potential hazards, ensuring absolute safety and compliance within sterile zones.
Continuous Improvement: Participate in initiatives designed to optimize equipment reliability and performance.
Education: National Trade Certificate, Vocational Qualification Certificate, or an equivalent discipline in Mechanical Engineering.
Experience: Minimum of 2 to 4 years of experience in a pharmaceutical, biotech, or sterile manufacturing environment.
Required Machinery Skills: Must have demonstrated, hands-on experience operating Lathe machines and milling machines.
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