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Process Systems Engineering Lead
Primary Objectives of this Job
Systems Engineering Lead is recognized within Takeda as a subject matter expert (SME) for the Singapore Biologics manufacturing facility with respect to all Systems Engineering activities. In this role, he / she is responsible to provide the necessary technical expertise with regards to System Engineering activities within the Site Engineering function.
Systems Engineering Lead is an integral member of the Singapore Process Engineering Team, he/she reports into the Process Engineering Manager of Site Engineering at the Singapore manufacturing site.
Systems Engineering Lead also interacts closely with the Operational Managers within the Site OLT at the Singapore facility to ensure that all Systems engineering activities are delivered to support reliable and robust manufacturing operations.
Systems Engineering Lead ensures that the Systems engineering team is staffed with the appropriate skills and capabilities to meet all Site Engineering functional goals.
Systems Engineering Lead will be part of Process engineering organization focusing on Right First Time delivery and following industry best practices to meet the strategic needs of the Takeda Singapore Manufacturing Plant.
Systems Engineering Lead also ensures that all Systems engineering activities result in fit for purpose assets which meet the business requirements (safety, functionality, capacity, capability, reliability) in a timely and cost effective manner.
Lastly he / she ensures that adequate technical and numerical support is provided to the Engineering Operations team to assure the success of engineering operations aspects of improvement projects.
• Lead, resource as appropriate and manage the portfolio of works associated with the Systems Engineering function.
• Be a Subject Matter Expert of System Engineering and provide the necessary technical engineering support to manufacturing systems to ensure that all manufacturing systems are available and fit for intended purpose.
• Fulfill all relevant external and internal compliance, EHS and quality requirements by focusing on Right First Time principles and using compliance as a competitive advantage
• Hire and train the workforce as necessary for the Systems Engineering function.
• Develop the Systems engineering team to make sure that all reports can fulf ill their assigned
functional goals and KPIs and contribute to the achievement of the overall Site Engineering
Department goals and KPIs
• Build a performance oriented culture with a focus on the Takeda Leader Behaviors, Continuous
Improvement and Right First Time
• Lead and coordinate the Quality Event process for Systems Engineering and ensure timely creation,
analysis and closure of events assigned to Site Engineering with special focus on achieving the
BOLT Quality KPIs
• Manage out of hours emergency / urgent response f rom Systems engineering team
• Liaise with the Manufacturing Teams and all Support Groups to ensure the fulf illment of product ion
targets and operational ef fectiveness
• Ensure the continuous improvement of all processes and workf lows to promote a Right First Time
culture and yield stable, lean and ef f icient manufacturing and business processes as well as an
ef f icient and lean organization
• Execute selection and manage service contractors and suppliers ensure right services, competency
level, cost and fulf illment to relevant Quality, EHS, Finance, regulatory policy and requirement
• Develop and maintain SOPs for relevant to system engineering functions, fulf illing all Regulatory
Requirements and EHS Policies
• Provide technical expertise to enable rapid trouble shooting and in depth investigations relating to
and equipment failure and mal-operation to maintain and improve asset availability and reliability
• Create and maintain appropriate training standards, guides and material for Systems Engineering
• Manage assigned projects within the Systems engineering function and support other Site
Engineering and all other departments at site in the planning and execution of projects
• Provide technical support for projects within engineering and other departments in the planning and
execution of projects
• Manage and update the assigned Process engineering cost Centre budgets and fulf illment of the
• Liaise with the Manufacturing Teams and all Support Groups to ensure the fulf illment of all plant
• Consult and seek alignment with the Engineering Operations, Automation and Capital Projects
functions within Site Engineering to achieve the optimal engineering structure and ef fectiveness of
services delivered to the Manufacturing Plant
• Consult and coordinate with GPET representatives within Global Engineering to share lessons
learned and best practices
• Liaise with global engineering functions to provide feedback on proposed and existing engineering
standards and implement these as appropriate within the facility
• Represent the Process Engineering (Systems engineering) Function in all internal and external
• Adhere to EHS requirements e.g. job risk assessment, observance of permit -to-work system
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s
Code of Conduct.
• Any other duties as assigned by supervisor.
Education and Experience Requirements
• Degree in Mechanical/Chemical engineering or equivalent Engineering Discipline with 8-10 years of experience is required.
• Diploma in Mechanical/Chemical engineering or equivalent Engineering Discipline with >10 years of experience is required
• Hands-on equipment maintenance and utilities experience in a cGMP manufacturing environment
• Must have excellent knowledge in operation and maintenance of manufacturing equipment; working experience in Biopharma equipment such as chromatography skid, ultrafiltration skid, bioreactor, CIP skid and etc.
• Preferred to have knowledge of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, RCFA, FMEA.
• Possess proficient computer skills and experienced in using MS Office software (Word, Excel and PowerPoint), MS Project and statistical tools i.e. Minitab, PI data book is preferred
• Thorough knowledge of current Good Manufacturing Practices (cGMP)
• Experience leading teams in a Systems Engineering function
Key Skills and Competencies
• Strong interpersonal skills and communication abilities. Able to manage up and across the organization
• Leadership experience; good people management skill
• Excellent in systematic trouble shooting and problem-solving skill
• Good writing skills essential for investigations, reports and proposals
• Customer Orientated
• Business acumen