Manufacturing Technician I - Aseptic (1st Shift)

Tolmar; Fort Collins (CO); On-site; USD 26,174 - 31,684; Full time

Job summary

Tolmar is seeking a Manufacturing Technician I to support the manufacturing department with a focus on injectable products, ensuring quality for patients.

The role requires working in a clean room, setting up labeling and packaging equipment, performing in-process sampling, and maintaining aseptic conditions. Applicants should have a high school diploma and prior manufacturing experience.

Qualifications

• High school diploma or GED 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 set up and operation of labeling equipment used to label pre-filled syringes and/or vials, including equipment in sterile 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 setup/disassembly/cleaning of syringe filling/stoppering equipment.
• Assist in preparation of equipment and parts for sterilization.
• Assist in bulking/filtration before aseptic filling.
• Maintain proper aseptic technique in an ISO 5-6 environment.
• Perform facility cleaning of critical aseptic environment per SOPs.
• Ensure product quality adheres to specifications.
• Follow SOPs and production records with 'Right the First Time' mindset.
• Participate in annual hazardous waste training and related procedures.
• Perform other duties as assigned.

Skills

cGMP knowledge

Documentation

Basic math

Computer literacy

Team collaboration

Stamina

Education

High school diploma

Tools

Labeling equipment

Semi-automatic packaging

Job description

Core Hours

Monday - Friday, 6:00 am - 2:30 pm

Training Hours

Training hours may vary

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. 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.

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.

Core Values

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Requirements

• High school diploma, GED or equivalent required.
• Experience in a manufacturing environment.
• Acceptable results on basic skill assessment.

Compensation And Benefits

• Pay: $19.95+ 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. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.