Aseptic Manufacturing Technician — Clean Room

Tolmar-7; Windsor (CO); On-site; USD 25,000 - 36,000; Full time

Job summary

Tolmar is seeking a Manufacturing Technician I to support aseptic injectable production in Windsor, CO. The role focuses on clean room activities, labeling and packaging of pre-filled syringes, in-process sampling, and maintaining strict cGMP documentation to ensure Right the First Time results.

The position requires standing for long periods, lifting up to 40 lbs, and working a Sunday–Wednesday schedule with every other Wednesday off.

Qualifications

• High school diploma or equivalent required.
• Experience in a manufacturing environment preferred but not required.
• Acceptable results on basic skill assessment.

Responsibilities

• Operate in a clean room environment requiring clean room gowning.
• Assist in the set up and operation labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas.
• Assist in the set up and operation of semi-automatic packaging equipment used to package pre-filled syringes.
• Perform in-process sampling, testing and inspection on the packaging line.
• Assist in the setup/disassembly/cleaning of the syringe filling/stoppering equipment.
• Assist in the preparation of equipment and parts for sterilization.
• Assist in the bulking/filtration process prior to aseptic filling.
• Maintain proper use of aseptic technique in an ISO 5-6 environment.
• Perform facility cleaning of critical aseptic environment as required to maintain a cGMP environment and in accordance with Standard Operating Procedures
• Ensure that product quality adheres to approved specifications.
• Perform job responsibilities in accordance with standard operation procedures (SOPs) and production records with an expectation of "Right the First Time."
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other duties as assigned.

Skills

cGMP basics

Documentation

Math & writing

Detail orientation

Team collaboration

Education

High school diploma or equivalent

Job description

Tolmar is seeking a Manufacturing Technician I to support aseptic injectable production in Windsor, CO. The role focuses on clean room activities, labeling and packaging of pre-filled syringes, in-process sampling, and maintaining strict cGMP documentation to ensure Right the First Time results.

The position requires standing for long periods, lifting up to 40 lbs, and working a Sunday–Wednesday schedule with every other Wednesday off.