Position Summary
The Production Officer is responsible for the manufacture of cell therapy products in accordance with approved manufacturing procedures, Good Manufacturing Practice (GMP) requirements, and applicable regulatory standards. The role supports all aspects of production operations, including aseptic processing, preparation of materials, operation of manufacturing equipment, completion of batch documentation, and maintenance of cleanroom environments to ensure the consistent production of safe, high-quality products.
Key Duties and Responsibilities
- Carry out aseptic processing activities inside cleanroom environments in accordance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and GMP requirements.
- Prepare, verify, and stage raw materials, consumables, reagents, and manufacturing equipment prior to production.
- Operate, monitor, clean, and maintain production equipment in accordance with approved procedures.
- Perform routine cleaning, sanitisation, and environmental preparation of production areas and equipment.
- Participate in equipment qualification, process validation, media fill simulations, and continuous improvement initiatives as assigned.
- Ensure compliance with GMP, biosafety requirements, occupational health and safety regulations, and company policies at all times.
Qualifications and Experience
- Bachelor’s degree in a science-related discipline (Biotechnology, Biomedical Science, Molecular Biology, Microbiology, etc.).
- Prior experience in GMP setting is not required but is preferred. Candidates without experience will be considered if they demonstrate strong technical aptitude and willingness to learn.
- Knowledge of contamination control procedures and aseptic techniques is advantageous.
- Understanding of GMP regulations, PIC/S standards, or ATMP-related guidelines is beneficial but not mandatory.
Competencies
- Strong communication skills and ability to work independently or as a part of team.
- Exceptional attention to detail and the ability to complete tasks in a precise and consistent manner.
- Good proficiency in English with strong technical writing skills
- Only Malaysians need to apply
Job Type: Full-time
Pay: RM2,500.00 - RM3,000.00 per month
Benefits:
- Free parking
- Health insurance
- Maternity leave
- Parental leave
- Professional development
Application Question(s):
- This position is open only to Malaysian Citizen
Education:
Experience:
- Contamination control procedures and aseptic techniques: 1 year (Preferred)
- GMP Setting: 1 year (Preferred)
Work Location: In person