Process Engineer Supervisor

3 weeks ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Roles & Responsibilities

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 leonleong@recruitexpress.com.sg (Attn: Process Engineer)

Thank You.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Tell employers what skills you have

Lifesciences
Sampling
Troubleshooting
Predictive Analysis
Protein Purification
Technology Transfer
Multitasking Skills
Manufacturing Processes
GMP
Formulation
Cell Culture
Manufacturing Operations
Process Engineering
Unit Operations
Good Communication Skills
Hazard Analysis
Process Control
Manufacturing
Mechanical Engineering
Technical Support
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