Role & responsibilities

1. Operate process tanks, vial washing machines, depyrogenation tunnel, autoclave, vial filling line, and sealing machine in the aseptic manufacturing area.
2. Operate and monitor CIP, SIP, and formulation processes, including formulation tanks, solution holding tanks, and vial pasteurizer activities.
3. Execute and monitor aseptic area activities such as equipment cleaning, area cleaning, and material movement as per approved procedures.
4. Monitor equipment performance during operations and make necessary adjustments to meet production requirements and process parameters.
5. Support area qualification activities and execute equipment qualification and validation activities related to fill-finish equipment.
6. Maintain accurate and timely documentation of production activities through logs, forms, reports, and relevant databases.
7. Provide support in all assigned activities as per functional requirements to help achieve departmental and organizational goals.

Knowledge and Understanding of:

- GMP and aseptic manufacturing practices
- Fill-finish equipment operation
- CIP/SIP systems




- Formulation processes
- Equipment cleaning and area cleaning procedures
- Material movement in aseptic manufacturing areas
- Area qualification and equipment qualification activities
- Validation activities related to fill-finish equipment
- Production documentation requirements, including logs, forms, reports, and databases

Experience:

- 2 -4 years of relevant experience in aseptic manufacturing operations.
- Experience in sterile fill-finish operations, including vial filling, sealing, and sterilization.
- Exposure to formulation activities and equipment operation.
- Experience in operating equipment in a pharmaceutical or biopharmaceutical manufacturing environment is preferred.

Skills & Ability:

- Attention to detail
- Equipment handling skills
- Documentation accuracy
- Teamwork and coordination
- Positive communication skills
- Problem-solving ability
- Adherence to SOPs and GMP requirements
- Safety awareness
- Ability to work in controlled aseptic environments

📌 Production Operator Fill Finish (Karnataka)
🏢 plasmagen biosciences
📍 Karnataka