Job Purpose 


Responsible for ensuring that facilities, layout and machinery used to produce new and existing materials and goods run to their maximum efficiency and output. This includes total preventative maintenance, managing breakdowns of mechanical, electrical and instrument equipment. 


Key Accountabilities 


Responsible for the following functions within the Engineering Department :- 
Equipment preventative and breakdown maintenance of the OSD facility. This includes the management of the preventative maintenance software programme. 
Managing and driving department excellence, e,g. Idea Log, process optimization and improvements, etc. 
Calibration related to the OSD facility. 
To ensure that engineering activities are carried out in a cGMP approved manner. 
Collaborates in the planning of new facilities and equipment or their replacement or sale. 
Recommends alteration, replacement, maintenance, construction, expansion, rehabilitation, disposal, inventory of engineering spares and execute construction required by such facility programmes. 
Prepare work authorization. 
SOP preparation, revision and ensuring ongoing training to personnel. 
Identification and evaluation of training needs for all departmental persons. 
Preparation and approval of change control, CAPA, deviation and risk assessment documents. 
Design tools, equipment, building, machinery and safety and protective devices. 
Any other assignment allocated by Associate Director - Engineering. 
Manpower requirements are identified for maximum productivity 
Budgets are prepared according to operational requirements 
Resource acquisition and other expenditure is planned as per budget 
Capital expenditure budgeting and execution
All queries are followed up and resolved in the shortest possible timeframe within policy framework 
A professional attitude is displayed when responding to a customers needs 
Methods for improving customer services are proposed, developed and continuously updated 
Internal and External customers are constantly updated as to the progress of their queries 
Familiar with recognized pharmaceutical systems supporting FDA/MHRA requirements such as DQ, IQ, OQ, PQ, Validation, Deviation Systems, Change Control and Quality improvement programmes 
Managing the maintenance of equipment, machinery, breakdown services, contractors and equipment 
To manage spares, equipment, installations, commissioning and disposal of all relevant assets according to company policy 
To manage and control all Engineering departmental deviations as agreed with the Head of Engineering 
Product knowledge is utilized to ensure information supplied to customers is up to date and accurate 
Programs are monitored to ensure target achievement 
Manage and control the planned preventative maintenance system 
Engineering issues are dealt with in line with customer service philosophy  
Engineering feedback is communicated to relevant departments 
Regular feedback sessions are held to ensure continual improvement  
Trend analysis and predictive maintenance programmes 
Review technical advancements 
Use of equipment and technology is maximised 
Equipment is maintained according to standard operating procedures  
Training is identified to accommodate innovation in technology, systems, capable of complying with inspection authority scrutinisation, ensuring change control and operator/user competency is current and reliable 
Upgrade, design parameters, philosophies, structural as required to enhance the functionality of equipment 
Hazardous situations are reported or resolved immediately 
Safety and health equipment is available and ready for use 
Perform monthly Health and Safety audits to ensure EHS Compliance to OSH Act 
Attend monthly safety meetings and take minutes recording all safety transgressions 
Incidents/accidents are prevented by effective operating of equipment and by following health and safety procedures 
Introduce Health and Safety procedures in accordance with current legislation 
GMR 2.1 appointment 
Learning achievements are acknowledged to improve staff performance and motivation 
Team effectiveness is facilitated and assessed against standards and contingencies applied when required 
On the job assessment and feedback occur timeously
Performance issues are accurately identified and action is instituted 
Potential conflict is resolved according to IR procedures 
Disciplinary action is taken according to the IR policy – in cases of extreme poor performances and inappropriate behaviour by staff
Staff performance is monitored against standards and regular feedback is provided 
Individual goals are developed and aligned to team goals and roles are clearly defined as per role profile 
Performance discussions are held regularly to identify learning requirements


Educational qualifications:  


National Diploma/BSc/BTech in Mechanical/Electrical/Chemical Engineering 
A Government Certificate of Competency (Advantageous) 


Relevant experience:  


5 years’ experience in Factory maintenance (Pharmaceutical preferred) 
At least 3 years’ experience in a leadership role in the maintenance/technical field 
Knowledge of control systems and experience with PLC’s 
Planned maintenance experience 
Knowledge of the OHSAct