MF Operator - Specialty Injectables

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

The Manufacturing Operator I – Specialty Injectables is responsible for basic setup and operation of manufacturing processes, with a focus on learning aseptic technique and GMP standards. This role performs basic setup and operation of processes supporting the Specialty Injectable team, ensuring products are made with quality for patients. This role will focus on Injectables (Sterile Filling/Bulking), Bulking (Polymer), or both.

• Adherence to Good Manufacturing Practices (cGMP) as they relate to sterile injectable manufacturing
  • Learn to 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
• Participates in annual hazardous waste training
• Learn to handle 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.
• Learn and support maintaining clean room standards and ensure adherence to safety protocols.
• Learns and accurately executes visual and physical checks of in-process and finished product
• Learns and 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
• Learn and adhere to all gowning procedures.

• Learns, develops basic understanding, follows guidance and support
  • Equipment set up, operation, disassembly and cleaning .
  • Sterile bulking process sterile using enclosed equipment train
  • Reading technical drawings/documents on the floor.
  • Operation of HMI systems to verify accurate functionality.
  • Contacting Maintenance as needed to resolve issues e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave
  • 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.
• Working knowledge of filling aseptic technique. Understanding of contamination control and clean room practices
  • Correctly performs aseptic interventions as per procedure
• Sets up and operates 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.

• Learn to participate in triage of atypical events with Quality, Maintenance, and MFG leadership as needed.
• Participates in on-the-job training for aseptic techniques equipment operation.
• Performance Metrics:
  Evaluated on…