Manufacturing Technician I - Aseptic

Tolmar•Windsor, CO

14h

About The Position

The Manufacturing Technician I provides general support for the manufacturing department, focusing on injectable products and ensuring products are made with quality for patients. The role works in clean-room and aseptic environments and supports production, packaging, equipment preparation and cleaning, and quality checks. Work is performed according to cGMP, standard operating procedures, and production records, with an expectation of getting work right the first time. The position also requires participation in hazardous-waste training and may involve managing and inspecting containers and tanks, generating or transferring hazardous waste, and responding to spills according to Chemical Spill Procedures. The technician is expected to operate within Tolmar’s Core Values, including people-centered work, adaptability, ethical conduct, continuous improvement, and accountability.

Requirements

High school diploma or equivalent.
Acceptable results on a basic skill assessment.
Working knowledge of current Good Manufacturing Procedures (cGMP).
Ability to interact professionally with peers and members of other departments in team settings.
Understanding of basic computer software.
Ability to follow and understand production records and procedures.
Basic math and writing skills to accurately document production activities in batch records and/or log books.
Attention to detail when documenting production activities.
Ability to operate on a fast-paced manual assembly line using basic production equipment.
Ability to manually assemble components.
Ability to stand for extended periods, up to 8 hours.
Ability to lift up to 40 lbs.
Ability to perform activities above the head.

Nice To Haves

Experience in a manufacturing environment.

Responsibilities

Work in a clean-room environment and wear required clean-room gowning.
Assist with setup and operation of labeling equipment for pre-filled syringes and/or vials, including equipment in sterile support areas.
Assist with setup and operation of semi-automatic packaging equipment for pre-filled syringes.
Perform in-process sampling, testing, and inspection on the packaging line.
Assist with setup, disassembly, and cleaning of syringe filling and stoppering equipment.
Prepare equipment and parts for sterilization.
Assist with the bulking and filtration process before aseptic filling.
Maintain proper aseptic technique in an ISO 5-6 environment.
Clean critical aseptic areas as required to maintain a cGMP environment and comply with Standard Operating Procedures.
Ensure product quality conforms to approved specifications.
Perform responsibilities in accordance with SOPs and production records, with an expectation of “Right the First Time.”
Participate in required annual hazardous-waste training and perform applicable hazardous-waste management, inspection, generation, or transfer activities.
Respond to spills according to the Chemical Spill Procedures.
Perform other duties as assigned.