Non-Aseptic Operator

TITLE

Non-Aseptic Operator I

Supervisor, Non-Aseptic Production, Raleigh

Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally. Visit  to learn more. Connect with Indivior on Linked In by visiting

The Non-Aseptic Production Operator I position is working in the roles of Vial Inspectors, Component Prep, & Compounding/Formulation. This person would be responsible for the operation of various types of processing and test equipment in environmentally controlled areas per Standard Operating Procedures. This would include but is not limited to steam sterilizers, formulation tanks and associated equipment, analytical balances, pumps, filter test equipment and other associated equipment.

As part of these responsibilities, the Production Operator I monitors cycles, and reviews data to ensure requirements have been met and completes all associated documentation.

• Complies with cGMP through adherence to SOPs, Master Batch Record Instructions, and company policies with a focus on quality and safety to produce parenteral products that improve the public health. Ensure training is in compliance with the job role/tasks before performing any activities in the production operation.
• Ensures that the equipment is cleaned and maintained properly, and the work areas are clean and maintained as required. This requires sanitization of walls, ceilings and floors as well as counter tops and tables. Clear and clean production lines as required before and after all operations.
• Responsible for reviewing raw process data to ensure process standards are met. Analytical reasoning ability and an understanding of the principles of cGMP production are required to accurately assess compliance to cycle standards.
• Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
• Communicates with Production Management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations, including but not limited to: equipment reliability, environmental problems, and potential quality and compliance concerns.
• Monitors manufacturing processes. Verify and document production activities both manually and on computerized systems, including batch records, logbooks, etc. to ensure requirements of production have been met.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions to supervisor.
• Setup and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for production operations. Operate a variety of production equipment, as mentioned above, to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required or directed. Utilize appropriate material handling equipment in accordance with standard operating safety policies.

• Follow established SOPs and documentation procedures
• Perform additional duties and responsibilities as assigned

• High School Diploma required
• Minimum one (1) year experience in a regulated environment or a Bio Works Certificate required
• Gowning experience in a classified area is required.
• Knowledge of cGMPs.
• Basic math and science skills and the ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills: both verbal and written.
• Attention to detail.
• Experience with batch records handling, and a broad understanding of pharmaceutical production.
• Mechanical aptitude preferred.

Physical Requirements of the Role:
Position requires continuous standing and walking. Frequent bending over and lifting and carrying up to 50 lbs. Must wear appropriate PPE as required. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products.

All personnel shall be instructed to report to supervisory personnel any health conditions…