Job Description

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.

Job responsibilities

• 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.

• 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.

Monroe Consulting