Plastic Manufacturing jobs

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JOB PURPOSE:

To operate, monitor, maintain, troubleshoot, and optimise Rommelag Blow-Fill-Seal (BFS) filling equipment and associated production processes to ensure the safe, efficient, and compliant manufacture of sterile pharmaceutical products. The incumbent is expected to apply practical expertise in BFS technology, polymer behaviour, plastics extrusion and moulding principles, machine process control, electronic and mechanical fault finding, and PLC-controlled automated systems. The role is responsible for machine operation, first-line maintenance, line clearance, line opening activities, process monitoring, quality assurance, GMP and QMS compliance, deviation support, root cause analysis, and accurate technical report writing.

MAIN TASKS / RESPONSIBILITIES:Production Operations

• Operate and monitor Rommelag BFS machines during production runs.
• Ensure production targets are achieved while maintaining product quality standards.
• Perform machine start-ups, shutdowns, product changeovers, and mould changes.

• Set up and control BFS process parameters relating to polymer extrusion, parison control, mould temperature, cooling, cutting, sealing, and container formation.

• Conduct line opening and line clearance activities in accordance with approved procedures.
• Monitor critical process parameters, including:
• • Temperature
  • Pressure
  • Fill volume
  • Bottle weight
  • Cycle times

o Polymer melt condition and extrusion stability

• • Sealing integrity

o PLC alarms, interlocks, sensor feedback, and automated control status

• Ensure correct machine setup and operational readiness before production commencement.
• Report production outputs, process deviations, and equipment issues accurately and timeously.

Equipment Maintenance & Troubleshooting

• Perform first-line maintenance on BFS equipment and associated systems.

• Use machine HMI and PLC feedback to identify alarms, abnormal operating conditions, process deviations, and equipment interlock issues.

• Conduct routine machine inspections and preventive maintenance activities.
• Troubleshoot mechanical, electrical, pneumatic, hydraulic, and process-related faults.

• Diagnose BFS-related process issues linked to polymer flow, extrusion instability, mould alignment, trimming, sealing defects, container formation, and plastic material performance.

• Identify and escalate equipment abnormalities for further technical intervention when required.
• Assist Engineering and Maintenance teams during major maintenance and breakdown investigations.
• Ensure equipment remains in optimal operational condition to minimize downtime.

Quality Assurance

• Perform in-process quality inspections according to SOPs, GMP requirements, and batch documentation.
• Monitor and inspect products for:
• • Leaks
  • Bottle weight compliance
  • Fill volume accuracy
  • Seal integrity
  • Flashing defects
  • Cosmetic defects
  • Particulate contamination
  • Print quality and traceability
• Complete all production and quality documentation accurately and legibly.
• Participate in deviation investigations, root cause analyses, and corrective action implementation.

• Support root cause analysis investigations by gathering process information, reviewing machine trends or events, identifying contributing factors, and documenting investigation outcomes.
• Prepare clear, factual, and GMP-compliant deviation, investigation, and technical reports where required.

• Assist with batch reconciliation and release-related activities.

Cleaning & Housekeeping

• Clean and sanitize BFS machines and production equipment according to approved procedures.
• Maintain housekeeping standards within manufacturing and cleanroom areas.
• Ensure adherence to contamination-control procedures and sterile gowning requirements.
• Participate in scheduled cleaning and sanitization programs.

Safety, GMP & Compliance

• Adhere to all Occupational Health and Safety regulations and company safety procedures.
• Always wear and maintain required PPE.
• Comply with GMP, SOPs, work instructions, and regulatory requirements.
• Participate in audits, inspections, training programs, and compliance initiatives.

• Apply pharmaceutical, GMP, and QMS training in daily operations, documentation practices, deviation handling, and compliance activities.

• Identify and report safety hazards, near misses, and unsafe conditions.

Continuous Improvement

• Contribute to process improvement initiatives aimed at increasing machine efficiency and reducing waste.
• Participate in root cause investigations and problem-solving activities.

• Use structured problem-solving tools to support root cause analysis, CAPA development, and documented effectiveness follow-up.

• Support implementation of corrective and preventive actions (CAPA).
• Assist in achieving departmental productivity, efficiency, and quality objectives.

Qualifications

• Grade 12 / Matric.
• National Diploma, N6, Trade Certificate, or equivalent qualification in Mechanical Engineering and/or Electrical Engineering.
• Technical qualification with exposure to automated manufacturing equipment.
• Pharmaceutical manufacturing, GMP, and Quality Management System (QMS) training would be advantageous.
• BFS Technology qualification from the Plastics Institute or equivalent training would be advantageous.
• Dual qualification in Mechanical and Electrical disciplines (advantageous)
• PLC, automation, or instrumentation training (advantageous).
• Training in deviation management, root cause analysis, CAPA, and technical report writing would be advantageous.

Experience

• Minimum 3-5 years' experience in a pharmaceutical, sterile manufacturing, FMCG, packaging, or production environment.
• Experience operating, maintaining, or troubleshooting Rommelag Blow-Fill-Seal (BFS) filling equipment is highly advantageous.
• Practical experience with BFS process optimisation, including parison formation, mould operation, sealing performance, container integrity, and process parameter control.
• Experience working with pharmaceutical-grade polymers and plastics manufacturing principles, including extrusion, moulding, cooling, trimming, defect identification, and material-related troubleshooting.
• Experience performing first-line maintenance, fault finding, and equipment troubleshooting.
• Experience conducting line clearance, line opening, and changeover activities.
• Experience working within a GMP-regulated environment.
• Exposure to pharmaceutical training, QMS processes, deviation management, and CAPA systems would be advantageous.
• Experience participating in root cause analysis investigations and compiling clear investigation reports would be advantageous.
• Experience operating automated production equipment and process control systems.
• Experience operating, interpreting, and responding to PLC-controlled machine interfaces, alarms, interlocks, sensors, and automated process controls.
• Strong electronic, mechanical, and PLC fault-finding experience on automated filling or manufacturing equipment.
• Experience in cleanroom manufacturing environments would be advantageous.

Languages

• Proficient in written and spoken English.
• Additional South African languages would be advantageous.

Other

• Ability to read, understand, and complete technical documentation, SOPs, batch records, and quality documentation in English.
• Ability to work rotating shifts, weekends, public holidays, and overtime as required.
• Ability to wear sterile gowning and PPE for extended periods.
• Strong mechanical, PLC and electrical troubleshooting capability.
• High level of attention to detail and commitment to quality.
• Ability to work independently and within a cross-functional team.
• Must demonstrate a strong commitment to safety, GMP compliance, and continuous improvement.
• Computer literacy, including Microsoft Office and manufacturing-related electronic systems.
• Operation of Equipment with PLC
• Reliable transport to accommodate shift work requirements.