Operator – Cartridge Filling Machine (with Isolator)

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.