Senior/ MSAT Engineer
MSAT Manufacturing Support team is a fast responsive team to support Value Stream in deviation investigations, process & equipment troubleshooting, validations and continuous improvement. Process team who provide process and technical support to enable the Value Streams to deliver their operational objectives optimally and in compliance with cGMP requirements. Areas of support includes deviation investigations and troubleshooting related to process equipment and; technical events; change management of equipment, facility, process and/or in-coming materials, QMS gap analysis, risk assessment of technical topics and production project management. Lead continuous improvement projects and process optimisation.
MSAT Manufacturing Support Engineers are also responsible for validating/qualifying the systems used to develop and/or manufacture products within manufacturing facility or pilot plant. 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 Engineers 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Support manufacturing operations to continue to operate in compliance with GMP and in an optimal manner :
- Managing technical deviations and CAPAs,
- Managing investigations of process and equipment issues,
- Subject Matter Expert (SME) for technical equipment and conduct relevant training,
- Technical troubleshooting,
- Managing process and equipments changes including CCs and SMRs,
- Quality and business-continuity risks,
- Gap analysis and follow up of QMS, Quality alerts and VSOPs where called for,
- Preparing documents as required to support the activities of the operations department.
- Lead root cause analysis sessions in support of quality deviations, equipment issues, and incident reporting.
- Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.
- Participate on technical team for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures.
- Support change management and implementation for changes to process equipment or the associated manufacturing processes and associated systems, provides training for technical staff on these changes
- Partner with VS to meet the production schedule, ensure commercial supply, uphold quality standards and drive towards zero defects.
- Assist in documenting 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, plan reports, etc.
- Develop risk assessments, risk mitigation strategies and risk plan. Develop technical impact assessments for all changes and develop execution plan.
- Establish experimental protocols, conduct experiments, analyse results, and document the information.
- 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/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
- Serve as a scientific and technical representative for process-related issues on equipment.
- Lead process/product/device 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 optimisation, 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 in 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 L1 audit.
- Participate in L2 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 time.
- 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 establishement of an active workplace safety. Be continuously on the lookout for anything that could lead to an accident. Be aware of the behaviour of colleagues too.
- Make daily safety inspections, provide input and feedback. about safety problems and solutions.
- Report all near miss accidents, dangerous occurrences or unsafe situations.
- Participate in enforcement inspections.
- Comply with all applicable safety standards.
We are looking for professionals with these required skills to achieve our goals:
- 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 3 years’ experience in Engineering, pharmaceutical industry or equivalent education preferred.
- Familiar with global regulations validation/qualification requirements.
- Good troubleshooting skill
- Knowledge in equipment used in vaccines manufacturing processes
- Experience with product development processes and project management 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
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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