Process Engineer

2 weeks ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

This role is for Process Engineer to support the process engineering work of upstream and downstream ,bioprocess systems/equipment and single-use technology equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.


Responsibilities:

  • Support in performing/reviewing process engineering drawings and calculations, as part of engineering design or as part of verification of calculations of vendors/client/other consultants. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat and mass balances, as well as other engineered calculations
  • Support in preparing/reviewing technical data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc.).
  • Support in preparing/reviewing risk assessments and HAZOPs.
  • Support in preparing/reviewing automation sequences, as required for Process Automation.
  • Coordination with other engineering disciplines and other crossfunctional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
  • Support the development of URS's, Risk Assessments, Commissioning and Validation strategies,
  • Commissioning project Plan, Validation Project Plan, Design Qualifications, Traceability Matrices,
  • Commissioning protocols, Qualification protocols, Validation protocols for pharmaceutical equipment and systems.
  • Ensure the client's process equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing.
  • Provides the client the tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
  • Act as the client's system technical owner for upstream, downstream equipment and other unit operations.
  • Assist the client's validation department with execution of qualification protocols including IQ, OQ, and PQ.
  • Author standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists.
  • Execution of activities like IGI, hardware FAT/SAT & installation verification associated with equipment changes and new equipment installations.
  • Review vendor turnover package documentation to ensure it meets all requirements.
  • Identify and assist in procurement of spare parts required for process equipment maintenance activities.
  • Manage construction activities associated with implementation of engineering projects.
  • Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, request from value stream stakeholders or GMP audits.
  • Timely closure of EHS and Quality event investigation and Corrective Actions / Preventative Actions (CAPA) tasks.
  • Provide on the floor troubleshooting support for the client's manufacturing operations especially with regard to equipment issues.
  • Raise and lead GMP change requests for implementation of changes to equipment and facilities.
  • Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements.
  • Responsibility to adhere to any applicable EHS requirements.
  • Any other duties as assigned by supervisor.
  • You may be involved with other aspects such as clientmanagement (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities).
Education and Experience Requirements

  • Degree in Biotechnology/Mechanical/Chemical engineering/ or equivalent.
  • Experience in an engineering role supporting cGMP operations in a pharmaceutical/ biopharmaceutical manufacturing plant is required.
  • Demonstrated mastery of technical drawings including PFDs, P&IDs, general arrangement drawings, and equipment design drawings is required.
  • Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
  • Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
  • Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
Key Skills and Competencies

Excellent Communication Skills

  • Ability to effectively communicate via writing and oral communication at all levels.
  • Express ideas effectively in individual and group situations (including nonverbal communication).
  • Ability to communicate to internal and external personnel and to communicate technical information to both technical and nontechnical people.
Project Management Skills

  • Ability to handle project, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
  • Use organizat

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