Manufacturing Technician I - Aseptic
Tolmar
Summary
Sunday - Wednesday, 5:00 am - 5:30 pm (every other Wednesday off)
Job description
Core Hours
Sunday - Wednesday, 5:00 am - 5:30 pm (every other Wednesday off)
Purpose and Scope
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.
Key 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, including container and tank management and inspections, generation of hazardous waste, and transfer of hazardous waste; respond to spills per the Chemical Spill Procedures
- Perform other duties as assigned
Knowledge, Skills & Abilities
- 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
Requirements
- High school diploma or equivalent required
- Experience in a manufacturing environment preferred but not required
- Acceptable results on basic skill assessment
- Working knowledge of current Good Manufacturing Procedures (cGMP)
- Understanding of basic computer software
- Understanding of basic math and writing skills
- Attention to detail
- 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
Benefits
- Quarterly incentive bonus
- Health benefits
Company overview
Tolmar is a fully integrated specialty pharmaceutical company founded in 2006, focused on the development, approval, and commercialization of innovative pharmaceutical products across urology, oncology, and dermatology therapeutic areas. The company has established itself as a leader in advanced long-acting injectable drug delivery technologies, with a particular emphasis on specialty injectables and prescription topical formulations. Tolmar's flagship products include ELIGARD® for advanced prostate cancer management, Fensolvi® for central precocious puberty treatment, and Jatenzo® for testosterone replacement therapy. With commercial headquarters in Buffalo Grove, Illinois and extensive manufacturing facilities in Colorado spanning over 340,000 square feet, Tolmar operates as a privately held organization with more than 1,100 employees. The company has successfully brought 22 marketed products to market supported by five New Drug Applications and 17 Abbreviated New Drug Applications, demonstrating its robust pipeline and commitment to addressing unmet medical needs through innovative pharmaceutical solutions.