Pharma Technician (Port Elizabeth) at Aspen Pharma Group

Description

• Monitor, maintain and repair equipment and machinery adhering to GMP and safety requirements.
• Plan and implement preventative and corrective maintenance.
• Ensure service equipment operates at optimal efficiency to meet planned levels of production.
• Innovate and apply process engineering techniques to ensure optimal functionality of production equipment and processes.

Requirements

Planning and Operational Support

• Act as a technical/ subject matter resource
• Facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Provide input into changes or improvements to processes, tools, and techniques
• Train staff on SOPs and maintenance of equipment/ machinery
• Audit and report non-compliance of production processes
• Prepare data and make recommendations of alternative ways to resolve Process and Engineering problems
• Institute appropriate changes in methods, designs and/or equipment
• Conduct product and method improvement investigations; assess the specifications of equipment and new materials and determine tooling requirements for production processes.
• Install, commission, and validate Equipment and Processes
• Programme new manufacturing methods
• Participate in forums for risk assessment and continuous improvements

Production Facility Maintenance

• Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
• Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOPs
• Repair breakdowns according to best practice, job cards and SOPs
• Troubleshoot machine breakdowns to identify cause of breakdowns
• Perform root cause analysis to identify cause of machine failures and quality deficiencies to minimize machine downtime
• Implement corrective actions to minimize machine downtime
• Isolate, remove and replace defective components
• Complete and submit work requisitions; Create and close job cards
• Maintain workshop, tools, and assets to standards
• Determine and request required parts, materials, and special equipment to maintain machines/ equipment
• Install, test, and validate machine operating efficiency

Mechanical Engineering

• Maintain calibration of machines according to SOPs and manuals, ensure machine safeguards are in place
• Identify and correct equipment deviations to avoid quality deficiencies; Reduce outsourced spending of repairs
• Rectify operational problems according to SOP
• Communicate process and equipment deviations to management
• Provide input into asset life cycle optimization and replacement

Reporting and record-keeping

• Provide standard record keeping and reporting functionality for area of work

Skills Required

Background/experience

• Trade Tested Artisan (Fitter/Fitter, Turner/Millwright or electrical) with 4 years’ post Apprenticeship experience as a trade tested artisan
• N4 in Engineering
• Pharmaceutical manufacturing Assistant will be an advantage
• At least 15 years manufacturing experience
• In depth experience in processing and maintenance of pharmaceutical manufacturing.

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Understanding of technical drawings / use of equipment manuals
• Ability to interpret and implement policies, processes, and objectives
• Physically capable of lifting/ moving heavy equipment

Competencies

• Interrogating Information
• Pragmatic Action
• Maintaining Accuracy