MF Operator - Specialty Injectables; 3rd Shift

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Join to apply for the MF Operator I - Specialty Injectables (3rd Shift) role at Tolmar

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.
• Injectables Specific Responsibilities
• 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.

• 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.
• Unde…