ROLE SUMMARY
· The incumbent will be responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development stage biological products.
· The engineer/scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development stage gene therapy products. Additional roles include using operational and technical knowledge to lead troubleshooting activities, tech transfer and start-up activities, investigations, analyse process data, and identify and implement moderately complex process improvements.
ROLE RESPONSIBILITIES
· Leading relevant process activities including protein purification or cell culture operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOP’s.
· Leading the setup and evaluation of unit operations, executions, and changeover (daily and long-term)
· Troubleshooting of complex process disturbances, identifying resolution and implementing corrective and preventive measures, as require
· Real time assessment of process performance and predictive analysis with identification of course correction (if required).
· Individual will be required to perform process monitoring, data analysis, and data preparation for presentation in several forums including project team meetings.
· Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables and approval of applicable documentation.
· Generate process overview presentations, sampling plans, and other tech transfer deliverables (if required).
· Capable of managing intra-departmental projects and performing relevant presentations with minimal supervision.
· Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment of complex process and equipment change controls to ensure a robust and capable solution with minimal supervision.
· Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times.
· The individual will be responsible for leading within the department as well as other departments to plan, communicate, and coordinate activities.
· Individual will assist in leading the inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
· Individual will be responsible for authoring and/or approving job-related documentation.
· Individual will drive the evaluation and assist in the implementation of new technology for process execution and/or analysis.
· Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be a coach.
· Individuals are responsible to ensure a safe work environment and to lead job hazard analysis and qualitative risk assessments.
· Individuals will be required to develop the multi-tasking skills of peers.
· Escalates and remediates with various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
· Individual should be involved in mentoring junior level scientists/engineers.
Our requirements:
- Min Degree in Biomedical Sciences or related sciences
- Min of 10 years’ experience in Process Engineer
- Must possess excellent team work and interpersonal skills with a strong emphasis on good analytical skills
- Possess good customer interactions skills
- Sound ability to troubleshoot and repair
- Good communication skills
If you are interested in the position, do kindly drop your most updated resume to [email protected] (Attn: Process Engineer)
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
