Biopharmaceutical Engineering Specialist

6 days ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Job Summary:
Biopharmaceutical Engineering Specialist

At PHARMENG TECHNOLOGY PTE. LTD., we are seeking a highly skilled Biopharmaceutical Engineering Specialist to join our team. This is a unique opportunity to work on process engineering work of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.

About the Role:
This role is responsible for supporting process engineering activities, including performing/reviewing process engineering drawings and calculations, preparing/reviewing technical data sheets, risk assessments, HAZOPs, automation sequences, and commissioning project plans. You will also be responsible for ensuring the client's process equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing.

Duties and 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. 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.
- 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 cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
- Commissioning project Plan, Validation Project Plan, Design Qualifications, Traceability Matrixes,
- 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.
- Author standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists.
- 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.
- 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.

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, 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.

Salary:
$80,000 - $110,000 per annum depending on experience.

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