- Location
- Navi Mumbai, Maharashtra, India
- Job type
- Full-time
About the role
Website:
techinvention.com
Job details:
- Job Title: Operator / Senior Operator – Sterile Filling & Formulation
- Department: Production / Operations (Injectable Line)
- Experience Required: 2 to 5 Years in Sterile/Injectable manufacturing (Vaccine experience preferred)
- Education: ITI / Diploma in Mechanical / Electrical / Instrumentation / Pharmacy / B.Sc.
Key Responsibilities includes :
- Aseptic Line Operations: Execute the setup, changeover, and smooth runtime operation of combi filler, stoppering unit, cap-sealing line.
- Isolator Mechanics: Experience in isolator handling for aseptic fill finish operations.
- Intervention Handling: Conduct non-routine or corrective interventions inside the Grade A zone strictly through glove ports using slow, deliberate movements to preserve unidirectional laminar airflow.
- Component Management: Safely execute material transfers utilizing RTP and Alpha/Beta port assemblies under cooling zone CS-LAF hoods.
- Gowning & Cleanroom Hygiene: Maintain full qualification for Grade A/B aseptic gowning. Adhere strictly to personal hygiene and cleanroom behaviour models to eliminate human-derived particulate shedding.
- Process Documentation: Fill out equipment logs, usage cards, and machine parameter records accurately in real-time, matching standard data integrity principles.
Technical Competencies
- Proven experience in operating barrier system technologies (Isolators).
- Hands-on mechanical familiarity with filling machine operation and trouble shooting.
- Understanding of cleanroom classifications (Grade A to D) and structural air-pressure cascades.
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