Sterile Technician

Responsibilities

• Ensure that utility systems are maintained in a state of compliance and reliably perform their validated function with maximum availability to support the different production areas.
• Execution of planned preventative maintenance program on utilities equipment which includes the purified water system, clean steam generation distribution system, electrical regulation system, transformers, emergency generators, chilled water plant, compressed air system and Air Handling Units(AHU), including dehumidifiers and Production equipment.
• Execution of planned preventative maintenance program on equipment within the sterile environment which includes aseptic filling area, compounding and preparation area. Water for Injection(WFI) plant, clean steam, particle monitoring system.
• Arrange and manage specialist contractors to perform specific tasks that fall outside the scope of internal resources, including evaluation of alternative key suppliers.
• Coordination of continuous improvement initiatives to establish the root causes on recurring maintenance problems and implementing action plans to achieve long term solutions.
• Responsible for the review and development of planned preventative maintenance (PPM) schedules in a quest to continuously improve the maintenance system.
• Participate in various quality system elements, including systems such as deviation management, root cause analysis, CAPA management, change control and quality risk management.
• Participate in validation activities within the area of responsibility to ensure that pharmaceutical systems such DOC, IQ, OQ and PQ are complied with as per SAHPRA and other regulatory requirements
• Ensure compliance with regulatory requirements with regards to Good Engineering Practices (GEP) and current Good Manufacturing Practices (GMP).
• Assist with the drafting and update of relevant department SOPs timeously.

Desired Skills

Desired Work Experience

Desired Qualification Level

About The Employer

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