Senior Technician: Utilities and Eye Drops, Midrand

• To ensure that utility systems are maintained in a state of compliance and reliably performs their validated function with maximum availability to support the different production areas. Ensure that operation and maintenance requirements of critical purified water system, boiler plant, steam distribution system, electrical reticulation system, transformers, emergency generators, chilled water plant, compressed air system as well as Air Handling Units (AHU) are adhered to.

Responsibilities:

• Ensure that the execution of planned preventative maintenance schedules for statutory inspections, such as boiler and lifting equipment, are prioritised.
• Drive continuous energy and water conservation in compliance with the company's sustainability and environmental commitments.
• Participate in various quality system elements, including systems such as complaint handling, recall handling, deviation management, root cause analysis, CAPA management, change control, and quality risk management.
• Participating in validation activities within the area of responsibility to ensure that pharmaceutical systems such DQ, IQ, OQ and PQ are complied with as per SAHPRA and other regulatory requirements.
• Ensure compliance to regulatory requirements with regards to Good Engineering Practices (GEP) and current Good Manufacturing Practices (cGMP)
• Assist with the drafting and update of relevant departmental SOPs timeously.
• Oversee execution of planned preventative maintenance program on utilities equipment which includes the purified water system, boiler plant, steam distribution system, electrical reticulation system, transformers, emergency generators, chilled water plant, compressed air system and Air Handling Units (AHU), including dehumidifiers.
• Oversee execution of planned preventative maintenance program on equipment within the sterile eye-drops environment which includes cleanroom filling area, compounding and preparation area, Water for Injection (WFI) plant, clean steam, particle monitoring system as well as leak detection and packaging area.
• 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.
• Assist with the review and development of planned preventative maintenance (PPMs) schedules in a quest to continuously improve the maintenance system.
• Provide 2nd level support on equipment maintenance and breakdowns, including call-outs.
• Safety, Health, Environment and Sustainability
• Ensure compliance with the Occupational Health and Safety Act, 85 of 1993 as amended within the area of responsibility.
• High Voltage (11 kV) switching and substation maintenance as per electrical installation regulations and SANS 10142-2 requirements.
• Ensure compliance with lock-out and work permit procedures by both internal and contract resources.

Minimum Requirements:

• N5 Certificate - Electrical/Mechanical/Millwright Trade Tested Artisan
• Desired Qualification – ND/BTech/BEng/BSc Mechanical or Electrical Engineering
• 5 – 10 years' experience within an FMCG production/manufacturing environment
• 3 years minimum supervisory experience within maintenance management environment
• Pharmaceutical industry experience within the sterile environment will be advantageous
• Water treatment plant, HVAC and control systems experience will be advantageous
• Quality and regulatory compliance knowledge, including cGMP will be advantageous
• Proven track record or demonstrated ability in electrical and mechanical engineering
• Computer literate in Microsoft office suite packages and computerized maintenance management systems (CMMS) experience such as SAP or Pragma.

Competencies:

• Proactive problem-solving approach and taking corrective actions to eliminate deviations
• Analytical, logical, conceptual, resourcefulness and problem-solving skills essential
• Assertive, resilient, action oriented, stable and ability to make decisions under pressure
• Methodical and systematic worker, comfortable with a fair amount of paperwork
• Self-motivation, high energy levels and perseverance to accomplish difficult tasks
• Ability to work independently and confident in applying own discretion in certain instances
• Ability to create trust and build a network of relationship with other functions
• Good oral and written communication skills towards all levels within the company
• Coaching and mentoring of staff, including basic understanding of Labour Relations Act
• Planning and organising, enforce instructions and procedures, adapting and responding to change, delivering results as well as meeting stakeholders' expectations