Manufacturing Operator

6 days ago

Windsor, United States Tolmar Full time
Description

Core Hours

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

Purpose and Scope

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.

Key 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 process.
  • Perform job 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. Automated packaging equipment includes (but is not limited to): semi-automated inspection, thermoformer, syringe connecting, labeler/vision systems, cartoning & 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 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.

Special Skills and Knowledge

  • 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 able to 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.

Core Values

  • The Manufacturing Operator I - Packaging is expected to operate within the framework of Tolmar‘s Core Values:
    • Consistently operate with the highest standards of ethics and compliance.
    • Take ownership of your actions, success and setbacks.
    • Respect each other and understand that honest collaboration is at the heart of our company success.
    • Go the extra mile to make things happen.
    • Be committed to all we do and the patients we serve.
    • Embrace change with enthusiasm.
    • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Communication

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

Education & Experience

  • 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.

Additional Requirements

  • Valid driver‘s license and acceptable motor vehicle record may be required.
  • Shift work in a manufacturing and warehouse environment.
  • May require overtime.

Compensation and Benefits

  • Pay: $23.33 per hour
  • Benefits summary: 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.



Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor‘s legal duty to furnish information. 41 CFR 60-1.35(c)

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