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

Competencies