Manufacturing Technician I - Aseptic (2nd Shift)

Tolmar Careers • Fort Collins, CO

1d • Onsite

About The Position

The Manufacturing Technician I provides general support for the manufacturing department with a focus on injectable products, while ensuring that our products are made with quality for our patients. This role involves working in a clean room environment requiring specific gowning procedures and operating labeling and packaging equipment for pre-filled syringes and/or vials. The position also includes performing in-process sampling, testing, and inspection, as well as assisting with equipment setup, cleaning, and sterilization preparation. Maintaining aseptic technique in an ISO 5-6 environment and performing facility cleaning to ensure a cGMP environment are critical aspects of this role. The technician is expected to adhere to standard operating procedures (SOPs) and production records with a focus on quality and accuracy. Responsibilities also extend to hazardous waste management and spill response.

Requirements

• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Interact with peers and members of other departments in team settings in a professional manner.
• Understanding of basic computer software.
• Ability to follow and understand production records and procedures.
• Understanding of basic math and writing skills to accurately document production activities in batch records and/or log books.
• Attention to detail is required for documentation in production documents.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to manually assemble components.
• Ability to stand for extended periods of time (up to 8 hours).
• Ability to lift up to 40 lbs.
• Ability to perform activities above your head.
• High school diploma, GED or equivalent required.
• Experience in a manufacturing environment.
• Acceptable results on basic skill assessment.

Responsibilities

• Perform job 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.

Benefits

• Pay: $19.95+ per hour DOE
• Shift Differential: $1.50 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED