Job Description

Upstream Manufacturing Operations

- Execute upstream production activities including:

- Microbial fermentation operations
- Seed train preparation and bioreactor inoculation
- Media and feed preparation
- Bioreactor monitoring and control
- Harvest operations (cell separation/primary recovery)

- Operate and monitor bioreactors (single-use or stainless steel) and associated systems.
- Control and record critical process parameters such as pH, DO, temperature, agitation, airflow, and feeding.
- Perform aseptic operations as per SOPs and batch manufacturing records (BMRs).

cGMP Documentation & Compliance
- Execute manufacturing activities strictly as per cGMP, SOPs, and approved batch records.
- Complete real-time documentation in BMRs, equipment logbooks, and process sheets.
- Identify and immediately report deviations, alarms, contamination risks, or abnormal observations.
- Support deviation investigations, corrective actions (CAPA), and change control implementation.

Equipment & Area Management
- Perform cleaning, sanitization, sterilization (CIP/SIP), and setup of upstream equipment.
- Support integrity testing,



equipment calibration coordination, and preventive maintenance.
- Ensure proper handling and storage of media components, supplements, and raw materials.
- Maintain housekeeping, 5S, and hygiene standards in classified areas.

- · Coordinate with Downstream, QC, QA, Engineering, and Warehouse teams for smooth batch execution.
- · Support technology transfer, scale-up, validation, and engineering batches under guidance.
- · Participate in training programs to continuously upgrade technical and GMP skills.

Technical Skills

- Hands-on knowledge of fermentation operations
- Understanding of seed train, media preparation, and harvest operations
- Familiarity with bioreactor control systems and process monitoring
- Basic knowledge of cGMP documentation and aseptic practices
- Comfortable working in cleanroom and shift-based operations

Work Experience

5 to 8 Years

Education

Masters in Biotechnology or Microbiology

B.Tech in Biochemistry

Competencies

📌 Trainee Executive - Production Microbial (Pune)
🏢 LUPIN
📍 Pune