MF Operator II - Specialty Injectables

Available Shifts

A

Shift: Sunday - Wednesday, 5:00 am - 5:30 pm, every other Wednesday off

B

Shift: Sunday - Wednesday, 5:00 pm - 5:30 am, every other Wednesday off

C

Shift: Wednesday - Saturday, 5:00 am - 5:30 pm, every other Wednesday off

D

Shift: Wednesday - Saturday, 5:00 pm - 5:30 am, every other Wednesday off

Purpose and Scope

The Manufacturing Operator II is responsible for executing manufacturing processes with a focus on Good Manufacturing Practice (GMP) compliance, aseptic proficiency and technical proficiency. This role demonstrates growing technical expertise, reliability in documentation, and begins mentoring junior staff. Operator II may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both.

Key Responsibilities

Maintaining High Standard of GMP

• Good working knowledge of current Good Manufacturing Practices (cGMP) as they relate to sterile injectable manufacturing
• Accurately execute and document batch record activities in compliance with GMP and SOP requirements.
  • Properly perform job duties ensuring all production activities and cleaning are correctly performed on batch records in accordance with cGMP standards
  • Demonstrate reliability and accuracy in all documentation and compliance activities.
• Compliance with safety protocols and clean room gowning requirements
• Coordinates and participates in annual hazardous waste training
• Handling hazardous raw materials and cleaning solutions as per safety procedures
  • 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.
• Maintain clean room standards and ensure adherence to safety protocols.
• Visual and physical checks of in-process and finished product
• Performs 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
• Ensures peers/ junior staff adhere to all gowning procedures.

Technical Expert

• Troubleshoot equipment and process issues with increasing independence and direct supervision.
  • Competently sets up, operates, disassembles, and cleans complex production equipment.
  • Good working knowledge of the sterile enclosed equipment train and bulking process
  • Understands and executes accurately technical drawings on the floor.
  • Basic knowledge of HMI systems to verify accurate functionality.
• Basic troubleshooting for resolution of equipment and process issues
  • Reads and understands reports and supports Maintenance as needed to resolve issues e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave
• Good working knowledge of Product Quality and Equipment: cause and effect related to product quality and equipment e.g valve set up, impact, and pressure safety for gaskets and steam.
• Participate in continuous improvement and deviation investigations.
• Troubleshoot equipment and process issues with increasing independence.
• Show proactive engagement in technical problem-solving and process optimization.

Other

• Supports the escalation and triage of atypical events with Quality, Maintenance, and MFG leadership
• Training and Development:
  Participates in on-the-job training for advanced equipment operation and troubleshooting.
• Performance Metrics:
  Evaluated on accuracy, compliance, reliability, and problem-solving in documentation and process execution
• Prepare for advancement by mastering routine tasks and demonstrating attention to detail.
• Master of equipment ownership and process troubleshooting.

Injectables Specific Responsibilities

• • Correctly performs aseptic interventions as per procedure
• Good working knowledge of filling aseptic technique and troubleshooting of filler: understanding of contamination control and clean room practices
• 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.

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…