Hazard and Risk Identification and Management

The Engineering and Maintenance Manager is responsible for managing and deploying resources to install, maintain and repair equipment and systems in the facility in line with organisational objectives. He/She translates the organisational strategies into tactical plans for the department and facilitates cross-functional collaborations and continuous improvements efforts. He manages resources to ensure that utilities and systems are adequate to support the achievement of organisational targets. He also develops plans to validate equipment and manage risks within the department. In addition, he is responsible for cascading key objectives to teams and individuals and managing team and project budgets. As a people manager, the Engineering and Maintenance Manager oversees manpower, financial, training and resource planning deployment within the Engineering and Maintenance department. The Engineering and Maintenance Manager is expected to serve as a role model in operational excellence in the department, and should be a personable and inspiring leader who can communicate well and influence internal and external stakeholders. He should also have a strategic, analytical mind to resolve problems and make effective decisions for the department when faced with complex situations.

The Engineering and Maintenance Senior Technician performs installation of equipment and systems, and also supervises installation and assembly work conducted by his team and external vendors. He/She maintains equipment and systems and is expected to conduct testing of equipment and systems independently. He is the first person to investigate equipment and system failures to determine the cause and repair work required. He manages the upkeep of systems that provide energy and utilities to the manufacturing facility, perform checks and rectify disruptions in energy supply. The Engineering and Maintenance Senior Technician has specialised technical knowledge of equipment and systems within the manufacturing facility and supports the innovation of equipment, systems and controls in the manufacturing facility. He should apply Standard Operating Procedures (SOPs) and Health, Safety and Environment regulations while carrying out his duties. The Engineering and Maintenance Senior Technician may be required to work on a shift to provide consistent technical support within the manufacturing facility. He should have an analytical mind and enjoy exploring solutions to problems independently. He possesses the intuition to step up to guide and supervise his team and interact with others to provide support across teams.

The Engineering and Maintenance Supervisor is responsible for overseeing and verifying installation and assembly work conducted within the manufacturing facility. He/She also has oversight of maintenance, testing and repair work carried out by his team. He contributes to the proactive management of energy and utilities within the system and liaises with vendors. The Engineering and Maintenance Supervisor also supports in the management of the department by recommending ways to improve department workflows and facilitating equipment replacements and improvements. He must have sound technical knowledge of equipment and systems within the facility whilst also being able to plan and manage Engineering and Maintenance activities to maximise resources and minimise equipment downtime. The Engineering and Maintenance Supervisor should be organised, have a systematic approach to solving problems and be able to communicate with team members and external parties to achieve the desired organisational outcomes.

The Engineering and Maintenance Technician supports the Engineering and Maintenance team by carrying out small-scale installations of manufacturing equipment and documenting installations and assembly works performed. He/She provides basic engineering technical support to ensure smooth running of manufacturing processes, including the maintenance of equipment and systems. He is expected to be able to interpret indicators of equipment and system damage and malfunction, and identify possible faults. The Engineering and Maintenance Technician also assists in the upkeep of systems that provide energy and utilities to the manufacturing facility. He must follow Standard Operating Procedures (SOPs) when conducting work and adhere to Health, Safety and Environment (HSE) regulations at all times to protect both employees as well as the quality of the biopharmaceutical products. The Engineering and Maintenance Technician works on a rotating shift in the manufacturing facility to provide continuous technical support. He should have an inquisitive mind and enjoy solving problems. While he should be disciplined and rigorous in following instructions and SOPs, he should also enjoy the interaction and camaraderie of working in a team environment.

The Production Manager communicates the production strategies, objectives, policies and processes to teams while maintaining oversight of the department's operational and financial status. He/She develops materials management strategies and approves Standard Operating Procedures (SOPs), ensuring alignment with regulatory standards and best practices. He prepares the production master plans and promotes collaboration and efficiency efforts to meet productivity objectives and targets. The Production Manager plans and manages the end-to-end production operations within the biopharmaceuticals manufacturing facilities and should be well-versed in Quality and Health, Safety and Environment (HSE) standards and Current Good Manufacturing Practices (CGMPs). The Production Manager works in a production facility that needs to comply with highly regulated standards. He makes important decisions fast and possesses excellent leadership and resource management capabilities. He should be able to consider a broad range of factors to arrive at optimal decisions to ensure business continuity especially during unforeseen production delays. He possesses flexibility to work under changing demands of production targets and is adept at building capabilities in the teams under his care towards common objectives.

The Production Team Supervisor is responsible for allocating responsibilities and overseeing operations on one or a few production lines whilst monitoring productivity rates against established targets. He/She also has oversight of materials management and reviews the Standard Operating Procedures (SOPs) for materials management, cleaning and sterilising activities. He is expected to propose and implement improvements to production workflows, equipment and systems to achieve production targets in a timely manner. The Production Team Supervisor must be able to plan and manage production activities in a way which drives operational efficiency and excellence, and should possess underlying technical knowledge of equipment and systems within the facilities. The Production Team Supervisor works in a production facility that needs to comply strictly with highly regulated standards. He is therefore meticulous and precise in his work and is confident in leading and motivating teams to perform their tasks in such an environment. He is analytical and systematic in investigating problems and decisive in implementing optimal solutions in the course of his work.