Process Engineer Supervisor (Biotechnology, Biopharma, Pharmaceutical MNC, Office Hours 5 days) #HDC

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 [Confidential Information] (Attn: Process Engineer)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599