Manufacturing Specialist - Specialty Injectables; 3rd Shift

Core Hours

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

Purpose and Scope

The Manufacturing Specialist - Specialty Injectables serves in an advanced technical capacity, taking responsibility for the operation of complex equipment, optimizing processes, and mentoring junior staff. This role may primarily focus on either Injectables (Sterile Filling/Bulking), Bulking (Polymer), or encompass both areas.

Key Responsibilities

• Act as the technical expert for setting up and operating complex manufacturing processes, handling all aspects of equipment setup, operation, disassembly, and cleaning independently.
• Lead advanced troubleshooting efforts and resolve equipment and process issues as they arise.
• Read and interpret reports, apply basic troubleshooting skills, and collaborate with Maintenance to address issues, such as filter testing, pressure hold tests, milling, SIP/VHP, PMS, and autoclave operations.
• Take ownership of batch record documentation and corrections, including supporting deviation investigations.
• Lead initiatives focused on process optimization and continuous improvement.
• Mentor and train junior operators in advanced equipment operation and troubleshooting.
• Perform responsibilities in compliance with standard operating procedures (SOPs) and production records, with an emphasis on "Right the First Time" execution.
• Record data in notebooks or laboratory forms, accurately calculating results to support manufacturing processes.
• Work in a clean room environment, adhering to gowning requirements, which include:
• 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
• Manage the issuance of bulk materials as needed for production.
• Clean manufacturing areas to maintain a cGMP environment in accordance with Tolmar Standard Operating Procedures.
• Identify minor maintenance needs on production equipment and assist with equipment setup.
• Perform second checker duties, ensuring that all production activities are accurately documented on batch records in compliance with cGMP standards.
• Ensure product quality consistently meets approved specifications.
• Assist and support specialty injectables activities and projects as required.
• Handle hazardous raw materials and cleaning solutions in accordance with all safety procedures and policies.
• Participate in required annual hazardous waste training, including involvement in container and tank management, inspections, hazardous waste generation, and transfer, and respond to spills according to Chemical Spill Procedures.
• Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform their job duties.
• Review and maintain log books, production records, and associated documents to ensure compliance with regulatory requirements, GMPs, and Tolmar SOPs.
• Perform visual and physical checks of in-process and finished products as needed.
• Assist with the formulation of bulk materials.

Injectables Specific Responsibilities

• • Set up and operate semi-automatic filling equipment for syringes used in both general and sterile manufacturing areas.
  • Set up and operate equipment associated with the Bulking process.
  • Assist with steam-in-place (SIP) operations on equipment used for sterile bulking processes.
  • Conduct biological sampling of general manufacturing clean room facilities.
  • Perform 100% inspections of pre-filled syringes.
  • Assist and support aseptic process development activities and projects as directed by the Specialty Injectables Manager.

Polymer Specific Responsibilities

• • Independently perform setup, operation, disassembly, and cleaning of production bulking, milling, and packaging equipment.
  • Complete cleaning, inspection, and lubrication of all Polymer area production equipment.
  • Act as the liaison between operations and maintenance staff for maintenance activities beyond the scope of manufacturing personnel.
  • Formulate bulk materials as required.
• Perform other duties as assigned.

• Possesses advanced working knowledge of current Good Manufacturing Procedures (cGMP), demonstrating expertise in applying these standards to all relevant manufacturing operations.
• Capable of standing for extended periods (up to 8 hours or more), maintaining effectiveness and focus throughout the shift.
• Able to learn and apply aseptic techniques, as well as work efficiently in an aseptic environment.
• Demonstrates strong proficiency with basic computer software, supporting daily operational needs and documentation requirements.
• Holds advanced knowledge of Human-Machine Interface (HMI) systems, particularly for basic troubleshooting tasks.
• Understands product quality and equipment operation thoroughly, including the cause-and-effect relationships that impact product quality and equipment performance (e.g., valve setup, impact, and pressure safety for gaskets and steam).
• Possesses comprehensive knowledge of the sterile enclosed equipment train and the bulking process,…