Sterile Technician

National Health Laboratory Service; Johannesburg; On-site; ZAR 300 000 - 450 000; Full time

Job summary

A leading health laboratory service in Johannesburg is seeking a Sterile Technician to ensure compliance of utility systems and execute maintenance on production equipment. The ideal candidate should have a National Diploma in Electrical/Mechanical Engineering and experience in a sterile pharmaceutical environment. Strong analytical and communication skills are essential for success in this role.

Qualifications

• Two to 4 years’ experience within sterile pharmaceutical production environment.
• Methodical and systematic worker, comfortable with a fair amount of paperwork.
• Ability to create trust and build a network of relationships with other functions.

Responsibilities

• Ensure utility systems are maintained in compliance and perform reliably.
• Execute planned preventative maintenance on utilities equipment.
• Participate in quality system elements, including deviation management.

Skills

Analytical skills

Problem-solving skills

Communication skills

Self-motivation

Education

National Diploma in Electrical/Mechanical/Millwright

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

Job description

Overview

BUSINESS UNIT: SOUTH AFRICAN VACCINE PRODUCERS DISCIPLINE: QUALITY ASSURANCE

LOCATION: SANDRINGHAM

POSITION: STERILE TECHNICIAN

PAY GRADE: C2

REFERENCE NUMBER: CORPSAVP0824/001-01 (99050-001-8047)

Key Job 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.
• Execute planned preventative maintenance program on utilities equipment including the purified water system, clean steam generation distribution system, electrical reticulation system, transformers, emergency generation, chilled water plant, compressed air system, Air Handling Units (AHU), including dehumidifiers and Production equipment.
• Execute planned preventative maintenance on equipment within the sterile antivenom environment including the clean room 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.
• Coordinate continuous improvement initiatives to establish root causes on recurring maintenance problems and implement action plans to achieve long term solutions.
• Responsible for the review and development of planned preventative maintenance (PPMs) schedules in a quest to continuously improve the maintenance system.
• Drive planned preventative maintenance schedule.
• Participate in various quality system elements, including deviation management, root cause analysis, CAP management, change control, and quality risk management.
• Participate in validation activities within the area of responsibility to ensure that pharmaceutical systems DQC, 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 updating of relevant department SOPs in a timely manner.

Minimum requirements & key competencies

• National Diploma (NQF Level 6) in Electrical/Mechanical/Millwright
• 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 relationships 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 oriented, stable and ability to make decisions under pressure.

Enquiries may be directed NdabenhleNgongoma @ [phone], e-mail application to [e-mail]