Sterile Processing Technician

The Parenteral/Steile Manufacturing Operator is responsible for carrying out aseptic manufacturing operations related to the production of sterile pharmaceutical products, including injectables, ophthalmics, biologics, or other sterile dosage forms. The role involves operating production equipment, maintaining cGMP compliance, adhering to aseptic practices, and ensuring product quality and operational efficiency.

Key Responsibilities

Production Operations

• Perform sterile manufacturing activities according to approved Batch Manufacturing Records (BMRs) and SOPs.
• Operate and monitor equipment used in sterile production processes such as:
• Washing Machines
• Sterilizers/Autoclaves
• Dry Heat Sterilizers (Depyrogenation Tunnel)
• Formulation Vessels
• Filling Machines
• Stoppering and Capping Machines
• Vial and Ampoule Processing Equipment
• Execute product changeovers and line clearance activities.

Aseptic Operations

• Work in Grade A, B, C, and D cleanroom environments.
• Follow gowning and aseptic procedures to prevent contamination.
• Participate in aseptic filling and sterile manufacturing activities.
• Ensure compliance with contamination control and cleanroom requirements.

Equipment Operation & Cleaning

• Perform equipment setup, operation, basic troubleshooting, cleaning, and sanitization.
• Carry out routine cleaning and maintenance activities as per SOPs.
• Report equipment abnormalities and assist engineering teams during maintenance.

Documentation

• Complete batch records, equipment logs, and production documentation accurately.
• Maintain compliance with Good Documentation Practices (GDP).
• Report deviations and unusual observations promptly.

GMP & Compliance

• Comply with cGMP, EHS, Data Integrity, and regulatory requirements.
• Follow all quality and safety procedures during manufacturing operations.
• Support internal audits and regulatory inspections.

Material Handling

• Dispense and transfer materials as per approved procedures.
• Verify status labels and material identification before use.
• Ensure proper handling and storage of components and finished products.

Continuous Improvement

• Support productivity and quality improvement initiatives.
• Participate in lean manufacturing and operational excellence activities.
• Assist in investigations related to deviations, incidents, and CAPAs.

Technical Skills

• Knowledge of sterile manufacturing processes.
• Understanding of aseptic techniques and contamination control.
• Hands-on experience with filling and packaging equipment.
• Knowledge of cGMP, GDP, and SOP compliance.
• Familiarity with cleanroom operations and gowning procedures.
• Basic troubleshooting skills for production equipment.

Preferred Experience

• Exposure to USFDA, MHRA, EU GMP, WHO-GMP regulated facilities.
• Experience in aseptic filling operations.

Interested candidates can send resumes to [email removed]