Manufacturing Operator I - Packaging (3rd Shift)

Core hours: Monday - Friday, 10:00 pm - 6:30 am

About the role

The Manufacturing Operator I – Packaging is responsible for the full set-up and safe, clean, efficient, and consistent operation of inspection and packaging equipment and all associated documentation for all Tolmar products. They provide manual assistance to the team using automated and manual equipment while ensuring that products are made with quality for our patients.

Responsibilities

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
• Record data in notebooks or lab forms and accurately calculate results to support the process.
• Work in a clean room environment requiring clean room gowning, including but not limited to:
  • Company-provided scrubs
  • Shoe covers
  • Hairnets (and beard covers as applicable)
  • Tyvek coveralls
  • Gloves
  • Face mask
• Set-up, operate, and monitor semi-automatic packaging equipment used to package pre-filled syringes, including but not limited to: semi-automated inspection, thermoformer, syringe connecting, labeler/vision systems, cartoning, and serialization.
• Properly load pre-filled syringes and components into automatic packaging equipment.
• Interface with human-machine interface (HMI) on automated equipment.
• Accurately document production activities using regulatory-controlled documents including production records and log books.
• Correctly perform inspections of packaged components.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and in accordance with Standard Operating Procedures.
• Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records.
• Qualify and maintain 100% inspections of pre-filled syringes.
• Responsible for assembly, disassembly, and sanitation of various equipment.
• Ensure that product quality adheres to approved specifications.
• Perform visual and physical checks of in-process and finished product as requested.
• Train new manufacturing employees to perform manufacturing processes.
• Conduct routine cleaning and monitoring of classified areas.
• Operate under the consistent supervision of a Lead Operator and/or Production Supervisor.
• 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 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.

Requirements

• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Working knowledge of basic computer software.
• Demonstrated ability to operate machinery.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Ability to follow and understand written production records and validation protocols.
• Understanding of basic math and writing skills to document production activities in batch records and/or log books.
• Must be able to keep accurate records and perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail for documentation in production documents and to inspect produced goods within specified requirements.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.

Qualifications

• High school diploma or equivalent required.
• 1 or more years of experience in a GMP manufacturing environment.
• 1 or more years of experience working with automated packaging equipment.
• Valid driver’s license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.
• May require overtime.
• Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment.

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, and sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative and proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency, and 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 and ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Communication

Interact with peers and members of other departments in team settings in a professional manner.

Pay

$23.33 per hour with a $2.50 shift differential. Eligible for a quarterly incentive bonus.

Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. For more details, visit Tolmar’s employee benefits summary.