Senior Process Engineer

4 weeks ago

Singapore TAKEDA MANUFACTURING SINGAPORE PTE. LTD. Full time
Roles & Responsibilities

Primary Objectives of this Job


Senior Process Engineer is a subject matter expert (SME) for the Singapore Biologics manufacturing facility with respect to all Process Engineering activities. In this role, he / she is responsible to provide the necessary technical expertise with regards to Process Engineering activities within the Site Engineering function.


Senior Process Engineer 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.


Senior Process Engineer 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.


Senior Process Engineer will lead/valuate process performance, yield/output and efficiency to assure the success of engineering operations aspects of continuous improvement initiatives.


Responsibilities


  • Be a Subject Matter Expert of Process Engineering and provide the necessary technical engineering support to manufacturing process - provide RCA/impact assessment; execute CAPAs; lead/coordinate process equipment/system change controls to ensure a robust and capable solution with no supervision
  • 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
  • Lead/coordinate the continuous improvement and innovation initiatives to promote a right first-time culture to improve process yields, reduce manufacturing related costs, and minimize process variability
  • Drive continuous efforts to minimize manufacturing/Equipment related Deviations/investigations
  • Lead assigned projects such as engineering modifications and fit-out for the tech transfers, be responsible to deliver projects to meet project objectives, especially related to Safety, Quality, Cost and Schedule
  • Support/Provide technical support for projects (CAPEX or Strategic) at site through the entire project life cycle from initiation to close-out.
  • Participate or lead, when required, in all investigations (contaminations, deviations, and discrepancies) relating to the manufacturing process.
  • Evaluation and assessment of unit operations, executions, and changeover (long-term)
  • Troubleshooting of highly complex process disturbances, identifying resolutions, and implementing corrective and preventive measures, as required.
  • Identifying, developing, and leading intra-departmental projects and performing relevant presentations with no supervision.
  • Responsible for authoring and/or approving job related documentation fulfilling all Regulatory Requirements and EHS Policies.
  • Required to review the assessments of junior engineer process monitoring, data analysis, and data preparation.
  • Support out of hours emergency / urgent response from Process engineering team
  • Create and maintain appropriate training standards, guides and material for Process Engineering. Provide training as necessary for the Process Engineering function.
  • Liaise with the Manufacturing Teams and all Support Groups to ensure the fulfillment of all plant goals
  • Liaise with global engineering functions to provide feedback on proposed and existing engineering standards and implement as appropriate within the facility
  • Completes all required documentation for proper traceability complying with Takeda requirements
  • Represent the Process Engineering Function in all internal and external audits
  • Drive the evaluation and assist in the implementation of new technology for process execution and/or analysis.
  • 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 with 5-7 years of experience is required.
  • Diploma in Mechanical/Chemical engineering or equivalent with >10 years of experience is required
  • Excellent process and equipment knowledge of biological drug substance manufacturing processes; upstream /downstream unit operations expertise highly preferable. working experience in Biopharma equipment such as chromatography skid, ultrafiltration skid, bioreactor, CIP skid and etc.
  • Knowledge/ Experience in DCS, PLC, OSIPI and Electronic Batch Management systems is an added advantage
  • Experience in the design and operation of biopharmaceutical manufacturing equipment / facilities.
  • Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and QbD
  • Good knowledge of EHS and risk management practices
  • 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

Tell employers what skills you have

Troubleshooting
Manufacturing Processes
Ultrafiltration
Chromatography
Upstream
Process Engineering
Unit Operations
Audits
Technical Engineering
Office Software
Regulatory Requirements
Manufacturing
EHS
Minitab
Technical Support

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