Aseptic Manufacturing

Biocon Biologics

is a fully integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

Position : - Aseptic Manufacturing

Experience : - 12 to 14 Years of Experiences

Key Responsibilities

1. Compliance & Documentation

Follow current Good Manufacturing Practices (cGMP) and ensure all activities are documented online and in real-time.

Ensure Good Documentation Practices (GDP) are followed for all records, logbooks, and checklists.

Adhere to entry and exit procedures for aseptic and controlled areas as per SOP.

Update status boards and maintain accurate online entries in BMRs and logs.

2. Environmental Monitoring & Equipment Handling

Monitor and record temperature, differential pressure, UV lamp hours, and LAF readings as per defined frequency.

Perform fogging, cleaning, and maintenance of aseptic, sealing, and sterile corridor areas.

Operate, clean, and maintain aseptic area equipment such as vial / cartridge filling machines, sealing machines, lyophilizers, LAFs, pass boxes, and garment cubicles per SOP.

Coordinate preventive maintenance and calibration of instruments and equipment with maintenance / instrumentation teams.

3. Aseptic Operations

Follow aseptic practices and behaviors in the sterile area at all times.

Perform solution filtration, capsule filter integrity testing, and aseptic connections as per SOP.

Conduct vial / cartridge filling and sealing operations for liquid and lyophilized products.

Carry out machine assembly, changeover, and troubleshooting during operations.

Load and unload vials in / from lyophilizer and autoclave as required.

4. Process & Quality Assurance

Perform filled volume checks and gas purging entries as per BMR / SOP.

Ensure filled and sealed containers are transferred to the packing area or cold room as applicable.

Participate in Aseptic Process Simulation (Media Fill) and gowning requalification as per plan.

Provide personnel monitoring samples (finger dab / gown) to microbiology after operations.

Carry out non-viable particle count as per defined frequency.

Execute development batches in coordination with R&D.

5. Safety & Training

Report any incidents, deviations, or accidents immediately to the supervisor.

Participate in cGMP, SOP, BMR, protocol, and other required trainings and maintain updated training records.