Executive recruitment company Monroe Consulting Group Malaysia's Healthcare Division is recruiting on behalf of a leading MNC in Biopharmaceutical, a company that innovates and revolutionise new solutions for everyday treatment. Our esteemed client has a global presence and manufactures various pharmaceutical products to treat patients across 120 different countries. They are seeking an experienced production engineer for the position of Assistant/Deputy/Associate Manager with their Upstream (Fermentation) department. The job will be based in Johor Bahru, Malaysia.
- Monitor the process operations and the batch performance as per standard operating procedures and product specifications in the plant.
- To practice and monitor the compliance with the requirements of CGMP.
- To prepare and revise necessary documents as and when required.
- Responsible for Process order and Inventory management in SAP system.
- Raw material planning for the batch and procurement from the warehouse, maintenance, and utilization as per production requirement.
- Reporting of Non-Conformities and deviations observed.
- To ensure timely maintenance of Upstream premises and equipment's in co-ordination with Maintenance and Automation department.
- To provide required initial and continuing training to Fermentation Area personnel and ensure the training is adapted.
- Managing and closure of OOS, change managements and deviations.
- To ensure timely execution of preventive maintenance and calibration programmes with the help of Maintenance and Automation department.
- Train the subordinates on process, operation, document entry, cGMP and safety compliance.
- Initiate, review and closure of the deviation, out of trend, out of specification and change controls.
Key job requirements include:
- Diploma/Degree Engineering, and related discipline or equivalent
- Preferably more than 6 years of upstream or fermentation experience.
- HACCP and CGMP experience are a must.
- Cleanroom experience is a must.
- Good problem solving, communication and analytical skills.
- A strong team player with good planning and interpersonal skills.
- Excellent analytical abilities and creative problem-solving skills.