Sterile Processing Technician

Sun Pharma; Kamrup Metropolitan; On-site; INR 300,000 - 560,000; Full time

Job summary

Sun Pharma in India seeks candidates for sterile production operations. The role involves performing sterile manufacturing per BMRs and SOPs, operating washing machines, autoclaves, filling and packaging equipment, and ensuring aseptic control in Grade A–D cleanrooms.

Responsibilities include line clearance, batch documentation, adherence to GDP and cGMP, and supporting continuous improvement initiatives in a regulated environment. Email resumes to [e-mail].

Qualifications

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

Responsibilities

• Perform sterile manufacturing activities according to BMRs and SOPs.
• Operate and monitor equipment in sterile production processes.
• Execute product changeovers and line clearance activities.
• Work in grade A–D cleanroom environments and follow aseptic procedures.
• Complete batch records, equipment logs, and production documentation.
• Comply with cGMP, EHS, data integrity, and regulatory requirements.
• Support lean manufacturing and continuous improvement initiatives.

Skills

Sterile manufacturing

Aseptic techniques

Cleanroom operations

GDP documentation

Tools

Filling machines

Autoclaves

Sterilizers

Job description

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 [e-mail]