Associate, Vial Washing

This role is responsible for performing a variety of tasks related to the processing and assembly of ingredients and pharmaceutical products within a regulated sterile manufacturing environment, with a specific focus on vial washing operations. The position operates vial washing equipment and associated apparatus to support production of sterile injectable pharmaceutical products. It handles vials, containers, and associated materials in accordance with established aseptic procedures and quality standards. The role supports vial washing operations including setup, operation, and monitoring of washing equipment to meet cleanliness and regulatory specifications. It performs general maintenance as required on vial washing equipment and associated apparatus to ensure operational continuity. Standard operating procedures are executed to meet current Good Manufacturing Practices and all associated documentation requirements are maintained accurately. The position ensures full compliance with regulatory requirements including FDA and EMA guidelines applicable to sterile pharmaceutical manufacturing. It actively participates in program or functional team projects aimed at developing process improvement methods and solutions to enhance quality, cost efficiency, and scheduling outcomes.

• Operate vial washing equipment and associated apparatus in compliance with established SOPs and GMP requirements

• Handle vials, containers, and associated materials with accuracy and adherence to aseptic technique and safety protocols

• Support vial washing operations including setup, operation, and monitoring of washing equipment to meet cleanliness specifications

• Perform general maintenance on vial washing equipment and associated apparatus as required to ensure operational readiness

• Execute standard operating procedures to meet current Good Manufacturing Practices (cGMP) requirements for sterile manufacturing

• Maintain accurate batch documentation records in compliance with regulatory and internal requirements

• Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines

• Participate in process improvement projects to enhance quality, cost efficiency, and production scheduling

• Conduct area cleaning and sanitization activities in accordance with cleanroom and aseptic GMP standards

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc.. - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses: