Sterile Technician

Tipp Focus (Pty) Ltd; Johannesburg; On-site; ZAR 50 000 - 200 000; Full time

Job summary

A leading pharmaceutical engineering firm in Johannesburg seeks a maintenance engineer with 5 to 10 years of experience in sterile production environments. You will oversee compliance maintenance, manage preventative maintenance programs, and coordinate improvement initiatives in alignment with regulatory standards. Ideal candidates will have a relevant degree and possess strong analytical and problem-solving skills.

Qualifications

• 5 to 10 years of experience in a sterile pharmaceutical production environment.
• Degree or equivalent in a related field.
• Comfortable with paperwork and documentation.

Responsibilities

• Ensure compliance with regulatory requirements including GEP and GMP.
• Manage planned preventative maintenance programs for utilities and equipment.
• Coordinate continuous improvement initiatives and root cause analysis.

Skills

Methodical and systematic worker

Pharmaceutical production

SAHPRA

GEP

GMP

CAPA management

Education

National Diploma (NQF Level 6) in Electrical/Mechanical/Mechatronics

Degree/B-Tech(NQF7) in BEng/BSc Mechanical or Electrical Engineering

Job description

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

• Methodical and systematic worker
• pharmaceutical production
• SAHPRA
• GEP
• GMP
• CAPA management

Desired Work Experience

• 5 to 10 years

Desired Qualification Level

• Degree

About The Employer

• National Diploma (NQF Level 6) in Electrical/Mechanical/Mechatronics.
• Degree/B-Tech(NQF7) in BEng/BSc Mechanical or Electrical Engineering (Desirable).
• Two (2) to 4 years\' experience within sterile pharmaceutical production environment.
• 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.
• Proactive problem-solving approach and taking corrective actions to eliminate deviations.
• Analytical, logical, conceptual, resourcefulness and problem-solving skills essential.
• Good oral and written communication skills towards all levels within the company.
• Assertive, resilient, action orientated, stable and ability to make decisions under pressure.