MSAT Manufacturing Support Lead

Site Name: Singapore - Tuas Posted Date: Jan 4 2023 Purpose 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 provides 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; 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 optimization. MSAT Manufacturing support Lead applies deep, specialized, broad expertise and is viewed as expert in the upstream/downstream activities for biopharmaceutical manufacturing. MSAT Manufacturing Support Lead is responsible to lead and mentor engineers and acts as a technical advisor, demonstrating technical leadership abilities through project leadership and mentoring in process improvement, validation of manufacturing processes and equipment that meet the US and global cGMP requirements. The MSAT Manufacturing Support Lead is responsible for optimising the performance of manufacturing systems (cost effective and efficiently within a dynamic business environment), ensuring manufacturing processes are robust and reliable, and for ensuring the successful hand-off to commercial production. She/he works closely with MSAT Manufacturing Support Manager with minimum or no supervision to accomplish all team goals and objectives. MSAT Manufacturing Support Lead directly implement, execute, and support validation strategy in use at the GSK Tuas Site ensuring it is harmonized with local, regulatory, and GSK standards. The role also includes management of validation activities to ensure timely completion and working in close cross-functional collaboration with member of other MSAT teams, Value Stream, Technical Services, Quality Control, Quality Assurance, Global Functions and Regulatory Affairs. Direct contact to other MPUs for knowledge sharing. Assist MSAT Product Stewardship and MSAT Technology Transfer teams in managing operational projects. MSAT Manufacturing Support Lead reports to MSAT Manufacturing Support Senior Manager. MSAT Manufacturing Support Lead will lead a team of Engineers/Snr Engineers, manage the performance of the team and help the team members to grow and develop. Key Responsibilities Area Manufacturing operations Provide technical leadership to the MSAT Manufacturing Support team to accomplish all team goals and objectives and to provide process and technical support to enable the Value Streams to deliver their operational objectives optimally and in compliance with cGMP requirements. Lead 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. Support manufacturing operations to continue to operate in compliance with GMP and in an optimal manner: Subject Matter Expert (SME) for technical equipment and conduct relevant training, Quality and business-continuity risks, Gap analysis and follow up of QMS, Quality alerts and VSOPs, 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 in technical teams for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures. The scope of work will include supporting GMP investigations and change controls, designing experiments, authoring and/or approving memos and technical reports, and improving manufacturing processes to reduce recurring deviations. Interact extensively with other departments including VS, QA, QC, SCM and TS. 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, analyze 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: Lead projects related to Process optimization, routine production issues troubleshooting, new equipment introduction and qualification. Lead 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: Lead/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. Lead/Execute equipment and process validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report. Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits. Lead/ Participate in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards. Lead/ 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 establishment 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. SME (where applicable): Provide technical consultancy to technical staff and non-technical staff as needed. Develop and deliver training materials and curricula, covering a range of technical, operational areas in a specified field. Communicate complex engineering designs/concepts to technical audiences in an efficient and effective manner. Monitor and assess new developments, industry trends, evolving regulatory expectations in area of expertise. Participate in network of local and global experts and sharing of best practices and learnings in area of expertise. Where applicable, oversee and mentor junior MSAT engineer on relevant business. Skills, Knowledge and Experience: Professional BS or higher degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology or related Life Science is required. Demonstrated skill and knowledge on cGMP regulations related to manufacturing of sterile and/or non-sterile operations, equipment, process, cleaning, and facility/utility validation strategies, protocol and report writing and execution. People management experience Technical At least 8 years of experience in pharmaceutical industry in a technical role (MSAT, validation, manufacturing, or Production support) with a good understanding of the cGMP and Health Authority regulatory requirements within the pharmaceutical industry. Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues. Strong understanding of Validation Life Cycle Management disciplines, cross functional skills, and processes (e.g., Continuous Process Validation, Process evaluation, …). Good understanding of FDA/EMEA/ICH/cGMP guidance documents. Proven track record in the development of systems, processes, and procedures to streamline operations. Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired. Business Highly effective communication, facilitation, negotiation and teamwork skills. Excellent interpersonal, written, and verbal communication skills. Strong background in pharmaceutical process support or manufacturing process optimisation. Experience applying quality regulations and standards (21CFR 820) is required. Experience in the leadership of continuous improvement initiatives and validation. Strong technical expertise with a solution oriented approach. Strong quality mindset and willing to take the ownership in front the challenges. Good risk management skills. Adaptable to fast-paced, dynamic work environment with shifting demand. Demonstrated ability to execute and organize and lead efforts to influence organizational change. Competencies Must be able to lead a team, manage the performance of the team and help the team members to grow and develop. Resourcefulness Must be able to work independently with minimum supervision, multi-task and support several projects simultaneously. Good communication skills, including writing, verbal, and interpersonal skills must be able to effectively communicate with external vendors and regulatory authorities. Strives for results: sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets. Cooperates transversally: shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organisation. Act for Change: creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes. Must demonstrate strong interpersonal & teamwork skills. Has demonstrated broad technical knowledge in related areas: Manufacturing processes, Validations and QA systems, Knowledge of GMP environment, Computer skills: Thorough knowledge of MS Project and SAP Sound knowledge of biopharmaceutical production processes. Sound knowledge of cGMP regulations and guidelines. Sound knowledge of Project management tools and good practices. Problem analysis and problem resolution at both a strategic and functional level. Result oriented and flexibility to adapt to changing priorities required. To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
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