Requirements
- Minimum N3 with trade. Trades in team balanced between Millwright, Electrician, Instrumentation Mechanician, Fitter and Turner. N6 with trade preferred.
- Minimum three years practical experience in the Engineering maintenance field, ideally within pharmaceutical manufacturing
- Cleanroom Gowning Competency
- Fundamental understanding of functionality of equipment, in the context of the manufacturing process, for area of responsibility
- Knowledge of industry best practice preventative maintenance techniques
- Terminally Sterilised pharmaceutical manufacturing process knowledge (LVP)
- Understanding of sanitisation, depyrogenation and sterilisation processes and equipment
- Proficiency in using Computerised Maintenance Management System for logging maintenance activities and building up of maintenance history on equipment.
- Working knowledge of a ICH Q10 Quality Management System and ability to complete to desired standard Risk Assessments, Change Controls and Events pertaining to equipment in area of responsibility
- Adhere to current data integrity standards
- Provide input to development of expense budget to cover maintenance requirements for area of responsibility and be proficient at monitoring spend to budget
- Proficient at performing maintenance and engineering projects within an aseptic pharmaceutical manufacturing environment
- Understand GMP requirements for the respective area of responsibility
- Proficient at providing input to development of SOP’s, Work instructions and Quick Fix routines for equipment in area of responsibility.
- Show competence in locating and execution of relevant SOP’s, Work instructions and Quick Fix routines for equipment in department.
- Proficiency at conducting detailed Root Cause Analysis with at least the 5 Why technique