The Maintenance Technician performs functions related to supporting the manufacture of drug products, such as setting-up, cleaning, and maintaining equipment and facilities. The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and internal policies and procedures in the performance of job duties.
- Support and adhere to established maintenance schedules.
- Maintain production and facility equipment in strict accordance with maintenance instructions, SOPs, and cGMPs.
- Complete all required data entries with detail and accuracy in real time.
- Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
- Recognize and report to immediate supervisor any process or equipment anomalies and/or deviations from accepted standards.
- Provide status updates on maintenance activities and operational challenges according to defined procedures.
- Execute machine changeovers between batches according to established SOPs and SLAs.
- Keep work area neat and orderly and observe all safety and compliance procedures.
- Seek process innovation and continuous process improvement in production area.
- Complete and conform to all training requirements for job role, including company-required and role-specific training.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
- Minimum of mechanical, electrical, or instrumentation craft qualification (preferably in the Pharmaceutical industry)
Preferably 5 years GMP/pharmaceutical maintenance work experience
Basic Microsoft Excel and Word skills
SAP and Track Wise knowledge desirable
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