Manufacturing Technician I - Aseptic (3rd Shift)

Tolmar•Windsor, CO

10h•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 operates within a clean room environment requiring specific gowning procedures and involves the setup and operation of 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, disassembly, cleaning, and preparation for sterilization. A key aspect of this role is maintaining aseptic technique in an ISO 5-6 environment and performing facility cleaning to ensure a cGMP environment. The technician is responsible for ensuring product quality adheres to approved specifications and performing all duties in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time." Additionally, the role involves participation in hazardous waste training and responding to spills according to established procedures.

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 or equivalent required.
Acceptable results on basic skill assessment.

Nice To Haves

Experience in a manufacturing environment preferred but not required.

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.