Machine Operator - Vial Filling & Sealing
Responsibilities
- Cleaning & operation of vial filling & sealing machines / PFS filling machine.
- Sterile area cleaning, equipment cleaning and recording of temperature & relative humidity of area.
- Assist in machine setting, assembling/disassembling, format changeover and maintenance of vial filling machine and PFS filling machine.
- Cleaning, wrapping and storage of filling machine accessories and format change parts.
- Assist in validation activity as per approved protocol such as media fill for filling simulation and validation of new equipment.
- Entry of daily operational details in respective log books.
- Coordination with material preparation area for washing, preparation and sterilization of filling machine accessories and primary/secondary packaging material.
- Coordination with warehouse for receiving, storage and transfer of active raw material, primary and secondary packaging material, semi-finished and finished goods.
- To ensure GMP compliance as per applicable national and international regulatory guidelines such as Schedule M & WHO.
- To carry out cleaning and sanitization of facility where applicable.
Qualifications
Experience
Required Skills
- Proficient in operating vial filling & sealing machines and PFS filling machines, including starting, stopping, monitoring, and adjusting machine settings.
- Knowledge and experience in cleaning and sterilizing equipment and the sterile production environment according to GMP standards. This includes familiarity with cleaning agents, sanitization methods, and proper documentation.
- Ability to assist with machine maintenance tasks like assembling/disassembling, format changeovers, and troubleshooting minor issues.
- Thorough knowledge and adherence to Good Manufacturing Practices (GMP), including national (Schedule M) etc.
- High level of accuracy and precision in machine operation, cleaning, gowning procedures and documentation to maintain quality and sterility.
- Ability to work in a cleanroom environment, potentially involving standing for long periods and performing repetitive tasks.
Seniority level
Employment type
Job function
Industries
- Pharmaceutical Manufacturing