Requeired Aseptic operator with Responsibility, Knowledge, and Skill set as mentioned below.
Core Responsibilities
Operate, clean, and perform routine maintenance on aseptic filling machines and associated equipment according to SOPs and operator manuals.
Ensure cleanliness and sterility of work areas, equipment, and production materials.
Troubleshoot equipment faults and solve production downtime issues as they arise.
Collect analytical samples and conduct online quality checks (package integrity, sterility, etc.) during production.
Assist and participate in aseptic process simulations, media fills, and validation activities for improved sterile practices.
Manage documentation including batch records, control sheets, and cleaning checklists, ensuring compliance with GMP and safety standards.
Required Skills and Qualifications
Knowledge of aseptic techniques and cleanroom protocols, including gowning and environmental monitoring.
Proficiency in operating and maintaining laboratory or production equipment (autoclaves, incubators, HMI monitors, laminar flow hoods).
Understanding of microbiology principles, sterilization methods, and risk assessment in sterile environments.
Ability to follow detailed SOPs and quality procedures; strong attention to detail and time management skills.
High School Diploma or GED typically required; experience in pharmaceutical, food, or biotech manufacturing preferred.
Sample Tasks
Foam cleaning walls, floors, control boxes, floor mats, and related surfaces in sterile environments.
Monitoring materials and loading aseptic supplies as needed.
Cross-training on other pieces of equipment and supporting plant production operations.
Operating material handling equipment (pallet jacks, reel carts, peroxide filling stations).