Sterile Manufacturing Operator

About the role

The Sterile Manufacturing Operator works in a regulated clean‑room environment to produce pharmaceutical products in strict compliance with Good Manufacturing Practices (GMP) and company SOPs. The role requires meticulous attention to detail, adherence to safety standards, and the ability to operate a variety of specialized equipment.

Key responsibilities

• Operate production equipment according to approved Batch Records and SOPs.
• Accurately complete, review, and verify Batch Records and related documentation.
• Perform weighing of active pharmaceutical ingredients (APIs) and excipients.
• Prepare solutions for filling operations following Batch Records.
• Conduct environmental monitoring and control activities.
• Set up and prepare isolators for the filling line, ensuring material compliance.
• Execute filter integrity testing as specified.
• Load and unload lyophilizers during production runs.
• Operate autoclaves for terminal sterilization.
• Clean, sanitize, and maintain production equipment and areas after manufacturing activities.

Required profile

• Commitment to GMP, cleanroom attire, and PPE requirements.
• Ability to follow detailed SOPs and Batch Records.
• Strong documentation and calculation accuracy.
• Willingness to work rotational days/weekends in an onsite environment.

Required skills

• Operation of pharmaceutical production equipment
• Weighing of APIs and excipients
• Solution preparation for filling operations
• Environmental monitoring
• Isolator setup for filling lines
• Filter integrity testing
• Lyophilizer loading/unloading
• Autoclave operation for terminal sterilization
• Cleaning and sanitization of production equipment