Manufacturing Lead Operator - Aseptic (1st Shift)

Key Responsibilities

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
• Work in a clean room environment requiring clean room gowning.
• Set up and manufacture clinical supplies and commercial pharmaceutical products in an aseptic environment.
• Set up and operate semi-automatic filling equipment for injectable products.
• Perform routine sampling and inspections of pre-filled syringes.
• Set up and operate compounding equipment for producing bulk material.
• Perform biological sampling of general manufacturing clean room facilities.
• Set up and operate semi-automatic packaging equipment for packaging pre-filled syringes.
• Document production activities using regulatory controlled documents.
• Clean manufacturing areas to maintain a cGMP environment.
• Inspect in-process and finished products as requested.
• Assemble, disassemble, and sanitize equipment.
• Perform second-check duties to ensure correct production activities.
• Train other Aseptic Operators and Technicians.
• Handle hazardous materials and follow safety procedures.
• Formulate bulk materials.
• Operate under minimal supervision.
• Perform other duties as assigned.

  Special Skills And Knowledge

  • Mastery of current Good Manufacturing Procedures (cGMP).
  • Standing for extended periods (up to 8 hours or more).
  • Proficiency in Microsoft Office (Excel, Word, Outlook).
  • Excellent verbal and written communication skills.
  • Adherence to production records and validation protocols.
  • Strong math and writing skills for documenting production activities.
  • Excellent attention to detail for documentation.
  • Ability to operate on a fast-paced manual assembly line.
  • Legible completion of required documentation.

    Core Values

    • Center on People: Support patient well-being and treat employees as valued partners.
    • Proactive & Agile: Adapt to change and respond swiftly.
    • Act Ethically: Conduct business ethically and comply with laws.
    • Constantly Improve: Enhance products, systems, processes, and services.
    • Accountable: Be honest, transparent, and clear in aligning with core values.

      Education & Experience

      • High school diploma or equivalent required.
      • 3 or more years of experience in a GMP manufacturing environment.

      Additional Requirements

      • Valid driver’s license and acceptable motor vehicle record.
      • Shift work in a manufacturing and warehouse environment.
      • May require overtime.
      • Ability to lead by example.
      • Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

        Compensation And Benefits

        • Pay: $33.00 per hour, depending on experience.
        • Eligible for quarterly incentive bonus.
        • Benefits summary: https://www.tolmar.com/careers/employee-benefits.

        Equal Opportunity Employer

        • Tolmar is an Equal Opportunity Employer.
        • We do not discriminate on the basis of 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.