Salary: Up to $8000
Duration: 6 months (start immediately)
Location: Kranji
Working Hours: Mondays to Fridays, office hours
Responsibilities:
• Ensures that the system in its totality (hardware, controls, sequence of operation) are fit-for-purpose and aligned with the business needs
• Support/Lead for the timing and strategy of process improvements and change controls
• Lead Quality Event (Deviation) process for Process Engineering and ensure timely creation, analysis and closure of events.
• Lead Change Control for Process Engineering and ensure timely creation, implementation and closure
• Responsible for Functional Specification Management.
• Provide support for weekly Plant Change Management meeting.
• Participate as Process Engineering representative on cross functional support team meetings.
• Primary liaison for engineering for RCAs and investigations (pulls in Process System & automation engineering as appropriate)
• Responsible for process safety assessments and hazard identification.
• Primary liaison for engineering for process FMEAs. Defines equipment operating ranges and ensures is aligned with process / product need
• Liaise with global engineering function to provide feedback on proposed and existing engineering standards and implement these as appropriate within the facility
• Target Delivery of results right first time
• Trouble shoots and resolves technical equipment problems and takes corrective action
• Timely closure of EHS and Quality event investigation and corrective & preventive action tasks.
• Lead CAPEX Project for Process Engineering and ensure timely implementation and closure
• Provide support for project teams for any new projects, makes recommendations based on experience
• Provide support for the evaluation and assist in the implementation of new technology for process execution and/or analysis
• Completes all required documentation for proper traceability complying with Takeda requirements
• Provide training to the end user on relevant technical aspects of installed plant assets
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Company’s Code of Conduct.
• Any other duties as assigned by supervisor.
Requirements:
• Minimum Degree in Chemical/Bio/Process/Mechanical engineering discipline
• Minimum 4 years of process engineering experience in Biologics, Pharmaceuticals and/or similar manufacturing industries
• Experience in bio-processing engineering in a manufacturing environment is highly desirable
• Knowledge of unit operations associated with cell culture and downstream processing including: media and buffer preparation, bioreactors, depth filtration, sterile filtration, single-use technologies and chromatography skids & columns
• Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
• Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines
• Experience in a GMP environment is preferred
• Management experience within a multi-disciplinary team is an added advantage
Interested candidates, please submit your resume to: [email protected]
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
