Job Description

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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Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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