Senior/MSAT Manufacturing Support Engineer

The Manufacturing Science & Technology (MSAT) Manufacturing Support team is an agile and fast responsive team that contributes to the MSAT department mission by driving commercial manufacturing processes improvements and providing technical expertise in various process disciplines. It also provides technical support to enable Value Streams to deliver their operational objectives optimally and in compliance with cGMP requirements.

Areas of support includes deviation investigations, process and Equipment troubleshooting, CAPA management, Change management of equipment, process and/or in-coming materials, QMS gap analysis and risk assessment of technical topics. Lead continuous improvement projects and process optimization.

MSAT Manufacturing Support Engineer is responsible for validating/qualifying the systems used to develop and/or manufacture products within manufacturing facility. They will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. MSAT Manufacturing Support Engineer directly implement, execute, and support validation strategy in use at the GSK Tuas Site ensuring it is harmonized with local, regulatory, and GSK standards. They manage, schedule, coordinate and execute assigned qualification or validation activities to ensure timely completion of the Validation Plan in coordination with the User, Technical Services, Quality Control, Quality Assurance and Regulatory departments. They support maintenance of all process equipment and critical systems at GSK Tuas site in a validated state. 

Direct contact to other MPUs for knowledge sharing. Assist MSAT Product Stewardship and MSAT Technology Transfer teams in managing operational projects.

M anufacturing Operations

Manage technical deviations and CAPAs. 

Manage investigations and troubleshooting of process and equipment issues.

Subject Matter Expert (SME) for technical equipment and conduct relevant training. 

Quality and business-continuity risks. Ensure necessary risk assessments are performed to justify or identify necessary mitigation plans.

Performs Gap analysis and follow up of QMS, Quality alerts and VSOPs. 

Preparing documents as required to support the activities of the operations department. 

Provide technical leadership and lead root cause analysis sessions in support of quality deviations, equipment/systems issues, and incident reporting and implement appropriate corrective and preventive actions to prevent recurrence. 

Participate in technical team for discrepancy and investigation resolution, equipment and process validation activities and training on new process technologies. 

Lead/Support change controls (CC) and implementation to process equipment or the associated manufacturing processes and systems, provides training to the team on these changes. 

Partner with production team to meet the production schedule, ensure commercial supply, uphold quality standards, and drive towards zero defects. 

Design processes to optimize efficient process flow, reduce process or product variability, reduce defects, improve process capability, uphold quality standards, and improve employee safety.

Perform changes/updates to manufacturing processes and work with manufacturing, engineering, other MSAT teams and QA validation to implement those changes.

Review/provide feedback and technical/scientific support on project deliverables, i.e., remediation initiatives, value creation projects (VCPs), technological advancements, strategic site priority projects (SSPs), etc. 

Establish experimental protocols, conduct experiments, analyse results, and document the information which can be an input to the investigation, CAPA, risk, change control or continuous improvement. 

Work closely with MSAT Product Stewardship team to identify and confirm critical process parameters needed for equipment and process validation. 

Continuous Improvement

Identify and implement potential process improvements in conjunction with manufacturing operations, MSAT Product Stewardship and MSAT Process Science & Manufacturing Technology teams (Process or equipment improvements, alarms management, OE initiatives, Infrastructure changes, new projects)

Propose process/product/equipment/system improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs, decrease process variability, and improve process robustness while maintaining regulatory compliance. 

Serve as a scientific and technical representative for process-related issues on equipment. 

Lead process/ product/ equipment/ system improvements, create data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborate with technical staff to implement process technology initiatives. 

Participate in start-up efforts of new equipment, software, or processes in manufacturing. 

Project Management

Manage projects related to Process optimization, routine production issues troubleshooting, new equipment introduction and qualification. 

Prepare documents such as protocols, reports, risk assessments to support trials and validations. 

Participate and contribute to design, development, validation strategy, and routine GMP activities. 

Represent MSAT department during technical transfer activities as required. 

Represent MSAT department during site GMP activities and participate on cross-functional teams. 

Audit Preparation and management

Support / lead Management Monitoring (MM) audit. 

Participate in Independent Business Monitoring (IBM) audit, corporate and regulatory inspections and front the inspector’s questions as Subject Matter Expert. 

Validations

Coordinate/execute the development of new validation processes or troubleshoot existing ones. 

Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines. 

Coordinate and communicate all testing with affected functional groups and evaluates test results. 

Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, Validation Reports, SOPs, Change Control. 

Documentation, Risk Assessments, Validation Deviations and Qualification Summary Reports with Value Stream, Technical Services. 

Execute equipment and process validation studies to include protocol preparation, scheduling, protocol execution, analyse data and compose a final report. 

Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits. 

Participate in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards. 

Participate in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment. 

Work with other departments to troubleshoot equipment, process, and validation issues such as deviation impact assessments and root cause analysis. 

Conduct Validation deviations and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA). 

Supports QA validation SMEs during audits. 

Environment, Health, Safety and Wellness

Support, promote and participate in site’s safety and wellness initiatives. Be a role model when appointed as a EHS Committee member, advocate and display safe behaviour and mindset at all times. 

Contribute and support EHS training activities aligned with Site vision and goals. 

Use PPEs correctly while working and follow the safety training and safety instructions and health rules and regulations. 

Contribute to the establishment of an active workplace safety. Be continuously on the lookout for anything that could lead to an accident.

Report all near miss accidents, dangerous occurrences, or unsafe situations. 

Participate in enforcement inspections. 

Comply with all applicable safety standards.

BS or higher degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science is required.

Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.

At least 4-5 years’ experience in Engineering, pharmaceutical industry or equivalent education preferred.

Experience in Ultrafiltration/diafiltration systems is preferred.

Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value

Familiar with global regulations validation/qualification requirements.

Equipment and process troubleshooting skills

Knowledge in equipment used in vaccines manufacturing processes.

Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.

Experience with product/process development and project management is a plus.

Lean Sigma/ Green Belt certification is a plus.

Highly effective communication, facilitation, negotiation, and teamwork skills are required. 

Excellent interpersonal, written, and verbal communication skills.

Adaptable to fast-paced, dynamic work environment with shifting demand.

Continuous improvement mindset.

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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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