Job Description

SUMMARY

The Sterile Operator plays a critical role in the aseptic production of sterile pharmaceutical products within a controlled cleanroom environment. This position is responsible for operating and monitoring sterile manufacturing equipment, ensuring compliance with industry regulations, and maintaining the highest standards of product quality and safety. The role requires attention to detail, physical stamina, and strong documentation practices to support accurate batch processing.

RESPONSIBILITIES

• Set up, adjust, and operate sterile production equipment in accordance with product requirements and size changeovers.
• Maintain continuous supply of materials to the production line to ensure smooth operations.
• Communicate effectively with filling and sealing operators, area supervisors, and management regarding production status, quality, and operational improvements.
• Complete required sterilization and release testing of compounded products.
• Conduct filter integrity testing and other compliance-related checks.
• Document production data, downtime, line clearances, and other batch-related information accurately and on time.
• Notify supervisors of any process deviations or equipment issues that may impact compliance.
• Perform other duties as required to support sterile manufacturing operations.

QUALIFICATIONS

• High school diploma or equivalent; associate’s degree preferred.
• Minimum of 2 years of related experience in sterile or pharmaceutical manufacturing.
• Strong computer and documentation skills.
• Must be able to meet physical requirements of the role, including sitting for extended periods and occasionally lifting up to 30 lbs.
• Demonstrated ability to adhere to aseptic and regulatory compliance standards.
• Strong communication skills and ability to work effectively in a team-oriented environment.

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