Job Description

Site Name: Singapore - Tuas
Posted Date: Nov 28 2023
The Manufacturing Support Engineer is responsible to support the set-up of the end-to-end production operations within the manufacturing facility with alignment to other site supporting functions so as to achieve productivity targets and objectives in a reliable, efficient and cost-effective manner, and meeting the Quality and Health, Safety and Environment (HSE) regulations and other regulatory standards. The Manufacturing Support Engineer provides process and technical support in transferring operations and technology for Hepatitis B (HBV) drug substance (DS) product manufacture from current production site in Belgium Rx59 to Singapore (SG) Tuas. He/ she partners with global MSAT, TLCM and R&D for process development and modernization activities to ensure the feasibility of the improved HBV process for SG. The Manufacturing Support Engineer explores new scientific technologies (e.g. digitalisation and data analytics) and equipment, determine their applicability, and qualifies new innovative technologies/processes that reduce cost, enhance features, or optimize manufacturing operations. He/she supports the design of a new facility that will incorporate state-of-the-art manufacturing technologies applicable for the HBV process. This role reports to and is a backup for the Process Development Lead or Operations Lead and will support him/her in any other tasks assigned.

Responsibilities

1. Manufacturing Support

• Responsible to support the set-up of the end-to-end production operations within the future manufacturing facility. Manufacturing support include:

• Participate in start-up efforts of new process equipment, software and processes in manufacturing, including validation activities
• Contribute to the identification and confirmation of critical process parameters needed for equipment and process validation
• Subject matter Expert (SME) for technical equipment and conduct relevant training
• Serve as a scientific and technical representative for process related issues on equipment
• Preparing documents as required to support the activities of the operations department

2. Operations Management (back-up)

• Responsible to support the set-up of the end-to-end production operations within the future manufacturing facility. Manufacturing activities include:

• Preparation and Supply of media, buffers and materials
• Manufacture of intermediates and drug substance

• Optimize the utilization of capacity and manufacturing resource optimally and sustain efficiency in:

• Manpower
• Facility
• Equipment
• Process

• Ensure facility operability is considered. Based on new HBV process, provide input to Process equipment design, facility design in terms of flows and footprint
• Collate process information to support detailed design
• Small equipment sourcing and material introduction
• Support commissioning/ qualification/ validation/ start-up needs and timelines

3. Process Development (back-up)

• Support process development plans for the HBV project, ensuring project deliverables are completed on time and within budget
• Research, develop and recommend new innovative technologies/processes that reduce cost, enhance features, or optimize manufacturing operations
• Execute activities, or partner with local MSAT Process Science and Manufacturing Technology team to design and develop processes to optimize efficient process flow, reduce process or product variability, improve process capability, and improve employee safety
• Develop, verify, and validate products from process development to successful commercialization
• Analyse all assigned areas of operations for potential improvement opportunities and makes applicable recommendations for process, system, procedure, and operational changes to improve operations and quality

4. Interface

• Develop relationship within the team and with other departments (including MSAT, QA, QC, TS, etc.) to ensure delivery of objectives.

5. Management

• Plan, manage and execute deliverables through proper and timely request and utilization of resources to ensure delivery of tasks.

6. Leadership (Senior Manufacturing Support Engineer)

• Coach and provide guidance to the Manufacturing Support Engineer in their execution of tasks
• To assist the Process Development Lead in ensuring the quality and delivery of tasks

7. Environment, Health, Safety and Wellness

• Participate in site\xe2\x80\x99s safety and wellness initiatives. Be a role model when appointed as a EHS Committee member, advocate and display safe behaviour and mindset at all time.
• Comply with all safety rules including the use of PPE, where applicable.
• Report all safety incidents and unsafe situations
• Participate in safety inspections and follow up on recommendations

• Manage safety CAPA and improvement projects
• Authors and revise safety risk assessments where required
• Perform permit-to-work (PTW) receiver and/ or issuer duties if appointed

8. Training & Development

• Proactively engage N+1 to discuss personal development and follow up on agreed development plan
• Provide guidance and support to new joiners ensuring his/ her smooth transition to the new workplace
• Conduct classroom and OJT training as assigned
• Development of training materials as assigned
• Guide others working in the Operations team (e.g. interns, staff on learning attachment programme)

Knowledge, Skills & Experience

• Degree in Chemical Engineering, Biotechnology, Life Sciences or other relevant field
• Relevant experience in the bio/pharmaceutical industry in Production, Process Development, Quality Control, R&D or MSAT
• Knowledge of cGMP and safety (biosafety)
• Knowledge in Biotechnology equipment and process
• Equipment and process troubleshooting skills
• Knowledge in Project Management
• Effective communication and team building skills
• Effective organization skills
• Effective project management skills

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