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 downstream department. The job will be based in Johor Bahru, Malaysia.

Job Responsibilities;

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure batches are manufactured according to production plan and without delays.
• Ensure adherence to standard operating procedures and that the team follows defined procedures.
• Responsible for production planning and inventory control to ensure raw material availability prior to batch start.
• Coordinate DS dispensing and ensure timely release of batches.
• Review and submit GMP documents to QA as per SLA.
• Investigate non-conforming/Deviations/OOS/OOT and implement CAPA, ensuring timely closure of associated documents.
• Maintain qualified status of all production equipment in coordination with CFT.
• Plan for CAPEX and OPEX requirements.
• Initiate, coordinate, and verify CAPA taken against nonconformance observed during audits.
• Guide team members in preparation of hazard and risk assessment register, aspect/impact register, and review adequacy.
• Follow established company procedures and policies pertaining to EHS and ensure effective implementation of EHS management system. Review progress/status of EHS objectives and targets periodically.
• Responsible for giving objectives and proper utilization of production personnel.
• Train and evaluate production personnel to minimize manual errors.
• Establish product life cycle management through validation cycle and continuous improvements towards high throughput. Maintain quality and robustness of the process.
• Involved in all activities related to Downstream Purification-1, Downstream Purification-2, and Buffer Preparation Area as an additional responsibility.

Requirements:

• Diploma/Degree Engineering, and related discipline or equivalent.
• Preferably more than 6 years of downstream 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.