We are seeking a highly skilled and detail-oriented skilled to manage and execute operations in sterile injectable manufacturing. The role involves handling vial washing, depyrogenation, aseptic filling, autoclaving, lyophilization (lyo), compounding, and microbiological quality control activities within a regulated pharmaceutical environment. The candidate must ensure compliance with cGMP, regulatory standards, and aseptic practices.

Key Responsibilities A. Production – Aseptic Area Operations

- Operate and monitor vial washing machines, depyrogenation tunnels, and ensure proper cleaning and sterilization cycles.
- Execute aseptic vial filling operations in classified cleanroom environments (Grade A/B/C/D).
- Handle autoclave operations including sterilization of equipment, components, and media using validated cycles.
- Manage lyophilization (freeze drying) processes including loading/unloading, cycle monitoring, and troubleshooting.
- Perform aseptic compounding activities as per batch manufacturing records (BMR).
- Ensure adherence to aseptic gowning procedures and cleanroom behavior protocols.
- Monitor environmental conditions (temperature, humidity, pressure differentials).

B. Equipment Handling & Validation

- Operate and maintain:
- Vial washing machines




- Sterilizers (Autoclaves)
- Lyophilizers
- Filling machines

- Support IQ/OQ/PQ validation activities for equipment.
- Perform routine calibration and preventive maintenance coordination.

C. Quality Control – Microbiology

- Perform microbiological testing including:
- Environmental Monitoring (EM) – viable & non-viable
- Water testing (PW, WFI)
- Sterility testing
- Bioburden analysis
- Endotoxin testing (LAL)

- Conduct media preparation, growth promotion testing, and culture handling.
- Monitor cleanroom microbial trends and initiate corrective actions.
- Maintain documentation for all QC microbiology activities.

Required Qualifications

- Education:
- B. Pharm / M. Pharm / B. Sc / M. Sc/ ITI/ Diploma

- Experience:

- 2–7 years in sterile injectable manufacturing / QC microbiology

Required Skills

- Strong knowledge of aseptic techniques and sterile manufacturing
- Hands-on experience with vial filling, autoclaves, and lyophilizers
- Expertise in microbiological testing methods
- Familiarity with cleanroom classifications and behavior
- Good documentation and analytical skills
- Understanding of regulatory requirements (USFDA, EU GMP)

📌 Production (injectable) and QC (Microbiology)
🏢 Talental Consultings
📍 India