MF Operator III - Specialty Injectables (3rd Shift)

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

Purpose and Scope

The Manufacturing Operator III – Specialty Injectables is a high level technical expert on 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. Operator III 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.
• Identify need for minor maintenance on production equipment and assist with set-up.
• 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.
• Assist and support any specialty injectables activities/projects.
• 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.
• Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform job duties related to their position.
• 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 operate 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.
• Excellent verbal and written communication skills.
• 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 abl