Process Analytical Technology Implementation

- Applies engineering principles and techniques to optimise the equipment and systems within the manufacturing facility. - Provides technical guidance and direction for the installation of equipment and systems. - He develops plans for the maintenance of equipment and systems, and recommends engineering solutions to troubleshoot faults. - Innovates equipment and systems, and contributes to manufacturing equipment and systems improvement projects by conducting feasibility assessments and tests on TC SMR technologies. - Manage energy resources and utilities by developing solutions to optimise machine availability and energy efficiency. - Ensure compliance with Standard Operating Procedures (SOPs), Health, Safety and Environment (HSE) regulations and Current Good Manufacturing Practices (CGMPs) within his purview. - Develops guidelines and conducts equipment qualification and validation in line with biopharmaceuticals manufacturing regulatory requirements. - Possess an enquiring and analytical mind and have a knack for investigating issues, analysing multifaceted engineering problems and developing solutions. - A strong team player who can guide and mentor others, and communicate technical advices and solutions to colleagues beyond the team.

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 Principal/Senior Engineer applies advanced engineering principles and techniques to troubleshoot complex engineering problems encountered within the manufacturing facility and provides expert technical advice to guide the installation and maintenance of equipment and systems. He/She is expected to lead the technical cross-collaboration with the Process Development/Manufacturing Science and Technology (PD/MSAT) department in order to identify appropriate biopharmaceuticals manufacturing equipment and optimise their functionalities. The Engineering and Maintenance Principal/Senior Engineer leads manufacturing equipment and systems innovation projects by guiding feasibility assessments and tests on TC SMR technologies. He is expected to review and approve solutions and initiatives to optimise machine availability while managing energy and utility use. He sets parameters for equipment qualification and validation in line with biopharmaceuticals manufacturing regulatory requirements. The Principal/Engineer must ensure compliance with Standard Operating Procedures (SOPs), Health, Safety and Environment (HSE) regulations and Current Good Manufacturing Practices (CGMPs) within his purview. The Engineering and Maintenance Principal/Engineer carries the responsibility of the in-house technical expert. He should possess a deep passion for analysing and resolving multifaceted engineering problems and be able to apply advanced critical and analytical thinking skills to deal with immediate situations. He should have a developmental and amiable approach in his interactions working as part of a team while guiding and mentoring others. He must also be able to communicate engineering concepts in a manner that will be understood by others within and beyond the team.

The Process Development/MS&T Engineer supports process development, monitoring and improvement activities for the biopharmaceuticals manufacturing facilities. He/She will analyse the critical material attributes of biopharmaceutical products, prepare Process Flow Diagrams (PFD), perform pilot tests and support technology transfer activities. He also assists in developing and updating Standard Operating Procedures (SOPs) for the manufacturing facility and supporting the delivery of associated training. The Process Development/MS&T Engineer should have deep understanding of the engineering and scientific concepts underlying the manufacture of the biopharmaceutical product and equipment involved in order to make significant contributions in determining how the product is made within the manufacturing facilities. The Process Development/MS&T Engineer should have a passion for innovation and continuous improvement and he applies this to his work, driving efficiency and improvement in TC SMR and existing manufacturing processes. He must be able work independently and exercise analytical and innovative thinking to analyse information, solve problems and improve existing methods and processes.

The Process Development/MS&T Manager reviews the operational and financial viability of developing, monitoring and improving biopharmaceuticals manufacturing processes within the facilities. He/She translates the departments objectives and priorities into actionable operating plans and Key Performance Indicators (KPIs) for Process Development/MS&T teams and tracks the progress. He is responsible for optimising internal processes while keeping in line with external guidelines and managing risks for the department. The Process Development/MS&T Manager is responsible for facilitating cross-departmental collaboration in order to successfully implement large-scale manufacturing processes for TC SMR biopharmaceuticals products or significant changes to equipment, systems and processes for existing products. The Process Development/MS&T Manager is expected to serve as a role model in the department and should be a personable and inspiring leader who can communicate well to influence internal and external stakeholders. He should be a champion for innovation and particularly enjoys leading efficiency and improvement initiatives across the organisation.

The Process Development/MS&T Senior Engineer leads the technical development, monitoring and improvement activities for biopharmaceuticals manufacturing processes within the facilities. He/She oversees the design and piloting of TC SMR processes and associated manufacturing facility layouts. The Process Development/MS&T Senior Engineer is the go-to technical expert for manufacturing processes across the facilities. He reviews the Standard Operating Procedures (SOPs) for manufacturing processes, collaborates with other departments to deliver training and implements technology transfer. The Process Development/MS&T Senior Engineer works primarily in production lines within the manufacturing facilities. He has a passion for innovation and continuous improvement and thoroughly enjoys critically analysing existing manufacturing processes in order to identify improvements or rectify deviations. He has strong communication and teamwork skills in order to successfully implement TC SMR and improved manufacturing processes in consultation and collaboration with other stakeholders.