Manufacturing Operator I - Injectables

Tolmar-7; Windsor (CO); On-site; USD 38,000 - 48,000; Full time

Job summary

Tolmar in Windsor, CO is seeking an Injectable Operator I to support the injectable team in a clean room environment. You will operate labeling and packaging equipment, perform in-process sampling, ensure quality per specifications, and assist with data acquisition and syringe filling processes.

You will train less experienced technicians, follow SOPs and batch records, and participate in hazardous waste training.

Qualifications

• High school diploma or GED required.
• 1+ years of experience in a GMP manufacturing environment.
• Acceptable results on basic skill assessment.

Responsibilities

• Operate labeling equipment and semi-automated packaging lines for pre-filled syringes.
• Perform setup/operational/disassembly/troubleshooting of syringe filling and packaging equipment.
• Conduct in-process sampling, testing, and inspection to ensure quality per specifications.
• Train less experienced technicians and follow SOPs and batch records.
• Assist in data acquisition for in-process testing and syringe filling.
• Maintain housekeeping, environmental monitoring, and documentation accuracy.

Skills

GMP manufacturing

Attention to detail

Documentation skills

Team collaboration

Safety awareness

Education

High school diploma or GED

Job description

The Injectable Operator I performs routine activities related to supporting the injectable team, while ensuring products are made with quality for our patients.

• Perform job in a clean room environment requiring clean room gowning
• Perform setup/operations/disassembly/trouble-shooting of labeling equipment used to pre-filled syringes and/or vials, including equipment in the sterile support areas.
• Perform setup/operation/disassembly/trouble-shooting of semi-automated packaging equipment used to package pre-filled syringes.
• Assist in the Setup/Disassembly/Cleaning/trouble-shooting of syringe filler
• Perform in-process sampling, testing and inspection on the packaging line.
• Ensure that product quality adheres to approved specifications.
• Perform syringe inspections using SIE (Syringe Inspection Equipment).
• Assist in setup data acquisition program for in-process testing for syringe filling.
• Operate data acquisition program for in-process testing for syringe filling.
• Perform setup/execution/disassembly for small bulk processing.
• Stage production lots for processing.
• Perform setup/execution/cleanup of needle cleaning process.
• Perform cleaning and environmental monitoring of process rooms.
• Order Supplies.
• Perform job responsibilities in accordance with standard operation procedures (SOPs) and production records with an expectation of “Right the First Time.”
• Train less experienced technicians.
• 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.
• Successfully qualification of internal syringe visual inspection program.

Core Values

• The Manufacturing Operator I - Injectables is expected to operate within the framework of Tolmar’s 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 or GED required.
• 1 or more years of experience in a GMP manufacturing environment.
• Acceptable results on basic skill assessment.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.