MF Operator - Specialty Injectables; 3rd Shift

MF Operator I - Specialty Injectables (3rd Shift)

Job Category
:
Production

Requisition Number: MFOPE
005358

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• Posted :
  November 11, 2025
• Full-Time
• On-site

Showing 1 location

Windsor CO
Windsor, CO 80550, USA

Core

Hours:

Monday - Friday 10:00 pm - 6:30am

Purpose and Scope

The Manufacturing Operator I – Specialty Injectables performs the set up and operation of processes related to supporting the Specialty Injectable team, while ensuring that products are made with quality for our patients. The Operator I may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both.

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 and Sterile Boot Covers
  • Hairnets (and beard covers as applicable)
  • Tyvek Coveralls
  • Gloves
  • Full-face masks/hoods
  • Goggles
  • Chemical Protection PPE
• Issuance of bulk materials.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by Tolmar Standard Operating Procedures.
• Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.
• Ensure that product quality adheres to approved specifications.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• 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.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and Tolmar Standard Operating Procedures.
• Perform visual and physical checks of in-process and finished product as requested.
• Assist with the formulation of bulk materials.
• Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
• Set-up and operation of equipment connected with Bulking process.
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
• Perform biological sampling of general manufacturing clean room facilities.
• Perform 100% inspections of pre-filled syringes.
• Assist and support any aseptic process development activities/projects as determined by Specialty Injectable Manager.
• Ability to learn Aseptic technique and work in an aseptic environment.
• Polymer Specific Responsibilities.
  • Perform the setup/operation/disassembly and cleaning of production bulking, milling and packaging equipment independent of maintenance personnel oversight.
  • Complete cleaning, inspection and lubrication tasks on all Polymer area production equipment.
  • Act as liaison between operations and maintenance staff when maintenance requirements are beyond the capability/scope of manufacturing personnel.
  • Formulate bulk materials.
• Perform other duties as required.

Knowledge, Skills & Abilities

• Strong working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Strong knowledge of basic computer software.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Good verbal and written communication skills.
• Ability to interact with peers and members of other departments in team settings in a professional manner.
• 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.
• Ability to keep accurate records and perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail required 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.
• Ability to learn Aseptic technique and work in an aseptic environment.
• Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
• Ability to lift up to 40 lbs.
• Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
• Ability to provide support as well as direction to Process Development personnel in the area.
• Ability to operate new production equipment with little to no previous experience.

Core Values

This position is…