Position Title:

Operator – Cartridge Filling Machine (with Isolator)

Department:

Manufacturing / Aseptic Filling

Reporting To:

Production Supervisor / Manufacturing Executive

1. Job Purpose

To operate, monitor, and maintain the cartridge filling machine housed within an isolator system under aseptic and GMP-compliant conditions, ensuring consistent product quality, safety, and adherence to regulatory guidelines.

2. Key Responsibilities

A. Machine Operation & Setup

• Perform setup, start-up, in-process monitoring, of cartridge filling machine and isolator.
• Ensure correct installation of format parts, filling needles, tubing, and change parts.
• Execute routine checks of machine parameters (speed, volume, stopper placement).
• Handle isolator glove ports safely and report glove integrity breaches.
• Shall have expertise in operation of decontamination Cycle for Isolator.

B. Aseptic Practices

• Perform operations under Grade A isolator with ISO 8 background, ensuring strict compliance with aseptic techniques.
• Participate in environmental monitoring activities during filling operations.
• Ensure adherence to gowning procedures, isolator entry/exit protocols, and material transfer SOPs.
• Shall be expertise in Aseptic interventions with out impacting the first air flow.

C. Documentation & Compliance

• Record all activities in Batch Manufacturing Records (BMRs) and logbooks in real-time.
• Follow approved SOPs, protocols, and cGMP requirements.
• Support investigations, deviations, and CAPAs related to filling activities.
• Maintain data integrity as per ALCOA+ principles.

D. Cleaning & Sterilization Support

• Perform pre- and post-operation cleaning of equipment and isolator.
• Verify sterilization and integrity of critical components (tubing, needles, stoppers, filters).
• Verify decontamination and integrity of Isolator.
• Participate in line clearance checks with QA before and after each batch.

E. Safety & Continuous Improvement

• Follow EHS guidelines, safe handling of isolator, compressed gases, and disinfectants.
• Escalate equipment malfunctions or abnormal observations promptly.
• Participate in training, continuous improvement, and operational excellence programs.

3. Qualifications & Experience

• Education: Diploma / B.Sc. / B.Pharm. / ITI in Mechanical, Electrical, or Life Sciences.
  • Experience:
  • 5-10 years in aseptic filling (cartridges, vials, or syringes).
  • Experience in isolator technology preferred.
• Knowledge:
  • cGMP, EU Annex 1, FDA aseptic guidelines.
  • Understanding of isolator systems, filling lines, and basic troubleshooting.

4. Key Skills

• Strong aseptic technique discipline.
• Mechanical aptitude for machine operation & troubleshooting.
• Attention to detail, accuracy in documentation.
• Teamwork and effective communication.
• Awareness of quality, safety, and regulatory compliance.

5. Performance Indicators (KPIs)

• Batch yield vs. target.
• Number of deviations/errors related to filling operations.
• Adherence to aseptic practices (interventions).
• Machine uptime and efficiency.
• Compliance in documentation and audits.