Manufacturing Technician I - Aseptic

Tolmar Careers•Windsor, CO

11d

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 a clean-room setting and supports aseptic manufacturing and packaging activities for pre-filled syringes and vials. Work follows standard operating procedures, production records, and cGMP requirements, with an emphasis on getting work right the first time. The position’s core hours are Sunday through Wednesday, 5:00 a.m. to 5:30 p.m., with every other Wednesday off. The role requires standing for extended periods, lifting up to 40 pounds, and performing tasks above head level. Manufacturing experience is preferred but not required; a high school diploma or equivalent is required.

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 your head.

Nice To Haves

Experience in a manufacturing environment.

Responsibilities

Work in a clean-room environment and follow clean-room gowning requirements.
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 follow Standard Operating Procedures.
Ensure product quality meets approved specifications.
Perform work according to SOPs and production records, with an expectation of “Right the First Time.”
Participate in required annual hazardous waste training and applicable hazardous waste handling, management, inspections, generation, and transfers.
Respond to spills according to Chemical Spill Procedures.
Perform other duties as assigned.