Technical Manufacturer ( Port Elizabeth) at Aspen Pharma Group

Description

• Set up, open, and change over the production line for processing.
• Monitor production performance to ensure optimal performance and conformance to standards and specifications.
• Perform first line maintenance on production equipment.
• Problem solving and troubleshooting.
• Provide on the floor system expertise.
• Ensure data integrity compliance to BMR for on time batch release.

Requirements

Planning and Operational Support

• Oversee work or serves as a lead technical expert.
• Optimise and facilitate implementation of current processes.
• Identify gaps in current policies and procedures.
• Propose changes/improvements to processes, tools and techniques.

Production Preparation

• Perform strip down, set up, adjustment, start up of production line.
• Perform Type A and Type B changeovers according to SOPs.
• Assist Validation on new projects (run speeds, equipment, etc.)
• Order change parts, tools and spares to meet production plan.

Production Processing

• Attend to mechanical and electrical breakdowns/ repairs as needed.
• Monitor line performance and make electrical/ mechanical adjustments where needed.
• Perform planned preventive maintenance as per plan/ schedule.
• Verify measuring equipment according to SOP and standards.

Routine Support Tasks

• Perform equipment pre checks according to SOP.
• Assist with campaign preparation.
• Perform equipment transfers according to SOPs and standards.
• Train new Technical Manufacturers.

Troubleshooting

• Perform root cause analysis to identify root cause of failures.
• Perform equipment adjustments to limit downtime; escalate major breakdowns to Engineering.
• Raise downtime notification with Production Leader
• Isolate and lock out machines to be set/maintained per SOP.
• Assist Engineering in the correction of equipment problems.

Process and System Improvements

• Perform product and method improvement investigations.
• Identify and execute improvement opportunities to reduce overall downtime and increase operational performance.

Admin and Record keeping

• Perform half hourly inspections.
• Attend shift meetings.
• Complete OEE reports
• Consolidate and analyse information; compile detailed reports.
• Monitor and control access to and set up of electronic databases.

Skills required

Background/experience

• Trade Tested Artisan with 2 to 4 years’ post Apprenticeship experience or National Diploma with 1 to 3 years’ related experience.
• Experience in production processes and operation or first line maintenance of production equipment

Specific job skills

• Advanced knowledge and understanding of setting up and running high speed PLC operated production equipment, process flow and associated critical control parameters.
• Advanced understanding of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Finalising outputs
• Following procedures
• Taking action
• Information gathering