Role Summary:
We are seeking a detail-oriented and skilled Sterile Filling Operator to join our production team. The role involves working in a cleanroom environment to ensure the manufacture of high-quality sterile pharmaceutical products in compliance with regulatory guidelines (SFDA, GMP, WHO)
Responsibilities:
- Operate sterile filling equipment for ophthalmic/sterile preparations as per SOPs.
- Load and unload materials, containers, and other components required for filling operations.
- Perform sterile cleaning operations and operate automated CIP/SIP systems.
- Maintain contamination-free operations and adhere to cleanroom protocols, including strict gowning procedures.
- Perform operations under ISO 5 (Grade A) and ISO 7 (Grade B) conditions.
- Ensure cleanliness and environmental standards in classified areas.
- Accurately complete batch records and logbooks following SOPs and regulatory guidelines.
- Comply with EHS policies and maintain a safe working environment.
- Perform routine cleaning and sterilization of production areas and equipment.
- Set up, operate, and troubleshoot production equipment, performing minor maintenance and coordinating repairs with maintenance teams.
Qualifications and Skills:
- Diploma in Engineering or related field.
- 2–4 years of experience in sterile pharmaceutical manufacturing or aseptic processing.
- Knowledge of GMP, SFDA, and WHO guidelines.
- Understanding of aseptic techniques and sterile processes.
- Strong attention to detail, quality focus, and good teamwork and communication skills.
